Hua Shan

All Publications

• Current state of gene therapy in sickle cell disease. Vox sanguinis Tang, M. S., Shan, H. 2024

  Abstract

  Sickle cell disease (SCD) is a type of hemoglobinopathy due to an autosomal recessive genetic defect, causing significant red cell sickling, multi-organ damage and long-term severe morbidities. Due to its complicated care and the impact on quality of life, a curative treatment for SCD is highly desirable. In recent years, gene therapy is emerging as a curative option for SCD, where autologous haematopoietic stem cells are collected from SCD patients and genetically modified ex vivo to reduce its sickling tendency before reinfusion. Although still largely investigational, a limited number of gene therapy options have been recently granted approval for SCD patients. Published data are still currently limited, but early studies have so far demonstrated the intended outcomes of less vaso-occlusive crisis and haemolysis. Nonetheless, despite its curative potential, larger clinical trials and longer follow-up period are still necessary to evaluate the safety of this treatment option, especially the risk of unintended genetic modifications. Furthermore, SCD patients frequently have limited access to specialty care; hence, the issues of affordability and accessibility to SCD gene therapy must also be addressed for it to benefit the appropriate patient population.

  View details for DOI 10.1111/vox.13612

  View details for PubMedID 38487952

• Use of Intravenous Albumin: A Guideline from the International Collaboration for Transfusion Medicine Guidelines. Chest Callum, J., Skubas, N. J., Bathla, A., Keshavarz, H., Clark, E. G., Rochwerg, B., Fergusson, D., Arbous, S., Bauer, S. R., China, L., Fung, M., Jug, R., Neill, M., Paine, C., Pavenski, K., Shah, P. S., Robinson, S., Shan, H., Szczepiorkowski, Z. M., Thevenot, T., Wu, B., Stanworth, S., Shehata, N., ICTMG Intravenous Albumin Guideline Group, Flores, J., Frappier, S., Hou, Y., Jean-Pierre, L., Jomaa, D., Kabir, M., Kadota, L., Lam, M., Ripsman, D. A., Sandarage, R., Staykov, E., Venes, A., Wan, M., Al Riyami, A., Brouwers, M., Callum, J., Daly, J., Denomme, G. A., Estcourt, L., Fergusson, D., Fung, M., Green, L., Greinacher, A., Hume, H., Jug, R., Kaufman, R., Kim, H., Louw, V., Matsushita, T., Murphy, M., Pink, J., Robinson, S., So-Osman, C., Stanworth, S., Szczepiorkowski, Z. M., Tobian, A., Wood, E. 2024

  Abstract

  BACKGROUND: Albumin is commonly employed across a wide range of clinical settings to improve hemodynamics, facilitate fluid removal, and manage complications of cirrhosis. The International Collaboration for Transfusion Medicine Guidelines developed guidelines for the use of albumin in patients requiring critical care, undergoing cardiovascular surgery, kidney replacement therapy, or experiencing complications of cirrhosis.METHODS: Co-chairs oversaw the guideline development process and the panel included researchers, clinicians, methodologists, and a patient representative. The evidence informing this guideline arises from a systematic review of randomized clinical trials and systematic reviews, in which multiple databases were searched (inception to November 23, 2022). The panel reviewed the data and formulated the guideline recommendations using Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. The guideline was revised after public consultation.RESULTS: The panel made 14 recommendations on albumin use in adult critical care (3 recommendations), pediatric critical care (1 recommendation), neonatal critical care (2 recommendations), cardiovascular surgery (2 recommendations), kidney replacement therapy (1 recommendation), and complications of cirrhosis (5 recommendations). Of the 14 recommendations, 2 had moderate certainty of evidence, 5 had low certainty of evidence, and 7 had very low certainty of evidence. Two of the 14 recommendations suggested conditional use of albumin for patients with cirrhosis undergoing large volume paracentesis or with spontaneous bacterial peritonitis. Twelve of 14 recommendations did not suggest albumin use in a wide variety of clinical situations where albumin is commonly transfused.CONCLUSIONS: There are currently few evidence-based indications that support the routine use of albumin in clinical practice to improve patient outcomes. This guideline provides clinicians with actionable recommendations on the use of albumin.

  View details for DOI 10.1016/j.chest.2024.02.049

  View details for PubMedID 38447639

• Incidence of formation of anti-D between patients with and without a history of solid organ transplant. Vox sanguinis Wali, J. A., Abdelmonem, M., Nguyen, A., Shan, H., Pandey, S., Yunce, M. 2024

  Abstract

  Solid organ transplant surgeries including liver transplants constitute a substantial risk of bleeding complications and given frequent national blood shortages, supporting D-negative transplant recipients with D-negative red blood cell products perioperatively can be difficult for the transfusion services. This study was designed to compare the incidence of alloimmunization after D-mismatched red cell transfusions between patients with and without a history of solid organ transplant at a single tertiary care hospital. The patients undergoing solid organ transplants are on strong immunosuppressive regimens perioperatively to help reduce the risk of rejection. We hypothesized that the use of these immunosuppressive agents makes these patients very less likely to mount an immune response and form anti-D antibodies when exposed to the D-positive red blood cell products perioperatively.At our center, D-negative patients who received ≥1 unit of D-positive red blood cell products were identified using historical transfusion records. Antibody testing results were examined to determine the incidence of the formation of anti-D and any other red cell alloantibodies after transfusion and these results were compared between patients with and without a history of solid organ transplant.We were able to identify a total of 22 patients over 10 years with D-negative phenotype who had undergone a solid organ transplant and had received D-positive red blood cell products during the transplant surgeries. We also identified a second group of 54 patients with D-negative phenotype who had received D-positive red blood cell products for other indications including medical and surgical. A comparison of the data showed no new anti-D formation among patients with a history of D mismatched transfusion during solid organ transplant surgeries.Among our limited study population, we observed a very low likelihood of D alloimmunization among solid organ transplant recipients. A larger, prospective study could help further evaluate the need for prophylactic D matching for red cell transfusions during solid organ transplant surgeries.

  View details for DOI 10.1111/vox.13589

  View details for PubMedID 38245847

• Current advances in 2022: A critical review of selected topics by the Association for the Advancement of Blood and Biotherapies (AABB) Clinical Transfusion Medicine Committee. Transfusion Metcalf, R. A., Cohn, C. S., Bakhtary, S., Gniadek, T., Gupta, G., Harm, S., Haspel, R. L., Hess, A. S., Jacobson, J., Lokhandwala, P. M., Murphy, C., Poston, J. N., Prochaska, M. T., Raval, J. S., Saifee, N. H., Salazar, E., Shan, H., Zantek, N. D., Pagano, M. B. 2023

  Abstract

  The Association for the Advancement of Blood and Biotherapies Clinical Transfusion Medicine Committee (CTMC) composes a summary of new and important advances in transfusion medicine (TM) on an annual basis. Since 2018, this has been assembled into a manuscript and published in Transfusion.CTMC members selected original manuscripts relevant to TM that were published electronically and/or in print during calendar year 2022. Papers were selected based on perceived importance and/or originality. References for selected papers were made available to CTMC members to provide feedback. Members were also encouraged to identify papers that may have been omitted initially. They then worked in groups of two to three to write a summary for each new publication within their broader topic. Each topic summary was then reviewed and edited by two separate committee members. The final manuscript was assembled by the first and senior authors. While this review is extensive, it is not a systematic review and some publications considered important by readers may have been excluded.For calendar year 2022, summaries of key publications were assembled for the following broader topics within TM: blood component therapy; infectious diseases, blood donor testing, and collections; patient blood management; immunohematology and genomics; hemostasis; hemoglobinopathies; apheresis and cell therapy; pediatrics; and health care disparities, diversity, equity, and inclusion.This Committee Report reviews and summarizes important publications and advances in TM published during calendar year 2022, and maybe a useful educational tool.

  View details for DOI 10.1111/trf.17475

  View details for PubMedID 37403547

• Hepatitis E virus seropositivity in an ethnically diverse community blood donor population. Vox sanguinis Mah, J. K., Keck, M., Chu, D. Y., Sooryanarain, H., Sahoo, M. K., Lau, P., Huang, C., Weber, J., Belanger, G. A., Keck, Z., Shan, H., Meng, X., Foung, S. K., Pinsky, B. A., Pham, T. D. 2023

  Abstract

  BACKGROUND AND OBJECTIVES: Hepatitis E virus (HEV) is an underrecognized and emerging infectious disease that may threaten the safety of donor blood supply in many parts of the world. We sought to elucidate whether our local community blood supply is at increased susceptibility for transmission of transfusion-associated HEV infections.MATERIALS AND METHODS: We screened 10,002 randomly selected donations over an 8-month period between 2017 and 2018 at the Stanford Blood Center for markers of HEV infection using commercial IgM/IgG serological tests and reverse transcriptase quantitative polymerase chain reaction assays (RT-qPCR). Donor demographic information, including gender, age, self-identified ethnicity, location of residence and recent travel, were obtained from the donor database and used to generate multivariate binary logistic regressions for risk factors of IgG seropositivity.RESULTS: A total of 10,002 blood donations from 7507 unique donors were screened, and there was no detectable HEV RNA by RT-qPCR. The overall seropositivity rate was 12.1% for IgG and 0.56% for IgM. Multivariate analysis of unique donors revealed a significantly higher risk of IgG seropositivity with increasing age, White/Asian ethnicities and residence in certain local counties.CONCLUSION: Although HEV IgG seroprevalence in the San Francisco Bay Area is consistent with ongoing infection, the screening of a large donor population did not identify any viraemic blood donors. While HEV is an underrecognized and emerging infection in other regions, there is no evidence to support routine blood screening for HEV in our local blood supply currently; however, periodic monitoring may still be required to assess the ongoing risk.

  View details for DOI 10.1111/vox.13487

  View details for PubMedID 37366233

• Serologic reactivity of unidentified specificity in antenatal testing and hemolytic disease of the fetus and newborn: The BEST collaborative study. Transfusion Lu, W., Ziman, A., Yan, M. T., Waters, A., Virk, M. S., Tran, A., Tang, H., Shih, A. W., Scally, E., Raval, J. S., Pandey, S., Pagano, M. B., Shan, H., Moore, C., Morrison, D., Cormack, O., Fitzgerald, J., Duncan, J., Corean, J., Clarke, G., Yazer, M. 2023

  Abstract

  The clinical significance of serologic reactivity of unidentified specificity (SRUS) in pregnancy is not clear based on available literature. The aim of this study is to determine if SRUS is associated with hemolytic disease of the fetus and newborn (HDFN).Retrospective data were collected from eight institutions over an 11-year study period (2010-2020), when available (5/8 sites). The outcome of the pregnancies with SRUS-no, mild, moderate, or severe HDFN-was determined.SRUS was demonstrated in 589 pregnancies. After excluding those with incomplete data, a total of 284 pregnancies were included in the primary HDFN outcome analysis. SRUS was detected in 124 (44%) pregnancies in isolation, and none were affected by HDFN. Of 41 pregnancies with SRUS and ABO incompatibility, 37 (90%) were unaffected, and 4 (10%) were associated with mild HDFN. Of 98 pregnancies with SRUS and concurrent identifiable antibody reactivity(s), 80 (81%) were unaffected, and 19 (19%) were associated with mild to severe HDFN. There was 1 case of mild HDFN and 1 case of severe HDFN in the 21 pregnancies with SRUS, ABO incompatibility, and concurrent identifiable antibody reactivity(s), and 19 (90%) were unaffected by HDFN. Among all patients with repeat testing, newly identified alloantibodies or other antibodies were identified in 63 of 212 (30%) patients. Although most were not clinically significant, on occasion SRUS preceded clinically significant antibody(s) associated with HDFN (3%, 5/188).The antenatal serologic finding of SRUS in isolation is not associated with HDFN but may precede clinically significant antibodies.

  View details for DOI 10.1111/trf.17276

  View details for PubMedID 36815517

• Plasma Exchange in Alzheimer's Disease. Transfusion medicine reviews Rohrer, L., Yunce, M., Montine, T. J., Shan, H. 2022

  Abstract

  Therapeutic plasma exchange (TPE) has traditionally been used to selectively remove pathologic contents including autoantibodies, abnormal proteins, immune complexes, or toxins from a patient's plasma. In addition to the removal of molecular contributors to disease, fluid replacement and infusion of beneficial plasma constituents including albumin can be tapered based on the pathophysiologic mechanisms of the offending disease. This treatment modality has shown efficacy in symptomatic relief and slowing of disease progression for various neurologic, immunologic, and hematologic diseases. This review outlines the rationale for TPE in the treatment of Alzheimer's Disease (AD) through a potential mechanism leveraging the concentration gradient of amyloid β peptides and the infusion of albumin, and critically reviews the clinical evidence for treatment of AD using TPE and albumin replacement. This review also highlights potential sources of bias that must be considered in conjunction with the evidence of efficacy for the use of TPE in AD.

  View details for DOI 10.1016/j.tmrv.2022.09.005

  View details for PubMedID 36357257

• Transfusion Outcomes between Regular and Low Yield Pathogen Reduced Platelets across Different Patient Populations in a Single Institution Tang, M., Shu, E., Sussman, H., Virk, M., Pandey, S., Shan, H., Pham, T. WILEY. 2022: 268A

  View details for Web of Science ID 000854334900392

• Transfusion outcomes between regular and low yield pathogen reduced platelets across different patient populations in a single institution. Transfusion Tang, M. S., Shu, E., Sussman, H., Virk, M., Pandey, S., Shan, H., Pham, T. 2022

  Abstract

  Pathogen reduction technology (PRT) effectively mitigates bacterial contamination in platelets but is more likely to produce low yield units. Although low dose transfusion using conventional platelets has not been associated with increased bleeding, these findings have not been reproduced with PRT-treated platelets.Platelet transfusions in a tertiary adult hospital were retrospectively reviewed. Comparisons were made between PRT-treated regular (PRT-PR) and low (PRT-PL) yield platelets. Outcomes examined included the number of platelets and RBCs transfused, transfusion-free interval, and corrected count increment (CCI). Subgroup analyses were also performed on hematology-oncology inpatients and outpatients, as well as non-hematology-oncology patients.Platelet utilization per patient remained mostly unchanged (mean 2.9-4.3 units per patient per month) even when the frequency of PRT-PL transfusion increased. Among 1402 patients examined, the number of platelets and RBCs transfused was not significantly different between patients first transfused with PRT-PR versus PRT-PL (mean number of platelet units = 2.8 vs. 3.1, p = 0.38; mean number of RBC units = 4.8 vs. 4.3, p = 0.93). Among 10,257 platelet transfusions examined, the transfusion-free interval (hazard ratio = 1.05, 95% confidence interval 1.00-1.10) and CCI (10.2 vs. 11.0, p = 0.70) were comparable between PRT-PR and PRT-PL units. Similar findings were observed in all subgroups, except for shortened transfusion-free intervals among hematology-oncology inpatients.PRT-PR and PRT-PL units may be used in an equivalent manner to maintain an adequate platelet inventory, since there was only a minor difference in time between transfusions.

  View details for DOI 10.1111/trf.17043

  View details for PubMedID 35924914

• Hospital red blood cell and platelet supply and utilization from March to December of the first year of the COVID-19 pandemic: The BEST Collaborative Study. Transfusion Lu, W., Yazer, M., Li, N., Ziman, A., Wendel, S., Tang, H., Tsang, H., Titlestad, K., Thibodeaux, S. R., Shih, A. W., Poisson, J. L., Pham, T., Pandey, S., Pagano, M. B., Shan, H., Murphy, M., Murphy, C., Savioli, M. L., Kutner, J. M., Hess, A. S., Fontaine, M. J., Fachini, R., Dunbar, N. M., Kaufman, R. M., Biomedical Excellence for Safer Transfusions Collaborative 2022

  Abstract

  BACKGROUND: At the start of the COVID-19 pandemic, widespread blood shortages were anticipated. We sought to determine how hospital blood supply and blood utilization were affected by the first wave of COVID-19.STUDY DESIGN AND METHODS: Weekly red blood cell (RBC) and platelet (PLT) inventory, transfusion, and outdate data were collected from 13 institutions in the United States, Brazil, Canada, and Denmark from March 1st to December 31st of 2020 and 2019. Data from the sites were aligned based on each site's local 1st peak of COVID-19 cases, and data from 2020 (pandemic year) were compared with data from the corresponding period in 2019 (pre-pandemic baseline).RESULTS: RBC inventories were 3% lower in 2020 than in 2019 (680 v. 704, p <0.001) and 5% fewer RBCs were transfused per week compared to 2019 (477 v. 501, p <0.001). However, during the 1st COVID-19 peak, RBC and PLT inventories were higher than normal, as reflected by deviation from par, days on hand, and percent outdated. At this time, 16% fewer inpatient beds were occupied, and 43% fewer surgeries were performed compared to 2019 (p <0.001). In contrast to 2019 when there was no correlation, there was, in 2020, significant negative correlations between RBC and PLT days on hand and both percentage occupancy of inpatient beds and percentage of surgeries performed.CONCLUSION: During the COVID-19 pandemic in 2020, RBC and PLT inventories remained adequate. During the first wave of cases, significant decreases in patient care activities were associated with excess RBC and PLT supplies and increased product outdating.

  View details for DOI 10.1111/trf.17023

  View details for PubMedID 35808950

• Current advances in transfusion medicine 2021: A critical review of selected topics by the AABB Clinical Transfusion Medicine Committee. Transfusion Metcalf, R. A., Cohn, C. S., Allen, E. S., Bakhtary, S., Gniadek, T., Gupta, G., Harm, S., Haspel, R., Hess, A., Jacobson, J., Lokhandwala, P. M., Murphy, C., Poston, J., Prochaska, M. T., Raval, J. S., Saifee, N. H., Salazar, E., Shan, H., Zantek, N., Pagano, M. B. 2022

  Abstract

  BACKGROUND: Each year the AABB Clinical Transfusion Medicine Committee (CTMC) procures a synopsis highlighting new, important, and clinically relevant studies in the field of transfusion medicine (TM). This has been made available as a publication in Transfusion since 2018.METHODS: CTMC members reviewed and identified original manuscripts covering TM-related topics published electronically (ahead-of-print) or in print from December 2020 to December 2021. Selection of publications was discussed at committee meetings and chosen based on perceived relevance and originality. Next, committee members worked in pairs to create a synopsis of each topic, which was then reviewed by additional committee members. The first and senior authors assembled the final manuscript. Although this synopsis is extensive, it is not exhaustive, and some articles may have been excluded or missed.RESULTS: The following topics are included: blood products; convalescent plasma; donor collections and testing; hemoglobinopathies; immunohematology and genomics; hemostasis; patient blood management; pediatrics; therapeutic apheresis; and cell therapy.CONCLUSIONS: This synopsis highlights and summarizes recent key developments in TM and may be useful for educational purposes.

  View details for DOI 10.1111/trf.16944

  View details for PubMedID 35713186

• Analyzing real world data of blood transfusion adverse events: Opportunities and challenges. Transfusion Jhaveri, P., Bozkurt, S., Moyal, A., Belov, A., Anderson, S., Shan, H., Whitaker, B., Hernandez-Boussard, T. 2022

  Abstract

  BACKGROUND: Blood transfusions are a vital component of modern healthcare, yet adverse reactions to blood product transfusions can cause morbidity, and rarely result in mortality. Therefore, accurate reporting of transfusion related adverse events (TRAEs) is paramount to improved transfusion practice. This study aims to investigate real-world data (RWD) on TRAEs by evaluating differences between ICD 9/10-based electronic health records (EHR) and blood bank-specific reporting.STUDY DESIGN AND METHODS: TRAE data were retrospectively collected from a blood bank-specific database between Jan 2015 and June 2019 as the reference data source and compared it to ICD 9/10 diagnostic codes corresponding to various TRAEs. Seven reactions that have corresponding ICD 9/10 diagnostic codes were evaluated: Transfusion related circulatory overload (TACO), transfusion related acute lung injury (TRALI), febrile non-hemolytic reaction (FNHTR), transfusion-related anaphylactic reaction (TRA), acute hemolytic transfusion reaction (AHTR), delayed hemolytic transfusion reaction (DHTR), and delayed serologic reaction (DSTR). These accounted for 33% of the TRAEs at an academic institution during the study period.RESULTS: Among 18637 adult blood transfusion recipients, there were 229 unique patients with 263 TRAE related ICD codes in the EHR, while there were 191 unique patients with 287 TRAEs identified in the blood bank database. None of the categories of reaction we investigated had perfect alignment between ICD 9/10 codes and blood bank specific diagnoses.DISCUSSION: Multiple systemic challenges were identified that hinder effective reporting of TRAEs. Identifying factors causing inconsistent reporting between blood banks and EHRs is paramount to developing effective workability between these electronic systems, as well as across clinical and laboratory teams.

  View details for DOI 10.1111/trf.16880

  View details for PubMedID 35437749

• How do I implement pathogen-reduced platelets? Transfusion Pham, T. D., Kadi, W., Shu, E., Pandey, S., Sussmann, H., Shan, H., Virk, M. S. 2021

  Abstract

  BACKGROUND: Several risk mitigation steps have improved the safety of platelets in regard to bacterial contamination, but this continues to be a concern today. A Food and Drug Administration (FDA) Guidance issued in December 2018 aims to further limit this risk. The guidance offers multiple pathways for compliance, and hospital blood banks will have to collaborate with blood donor centers to assess various factors before deciding which method is most appropriate for them.METHODS AND MATERIALS: Our institution considered several factors before moving forward with pathogen reduction technology. This included an assessment of platelet shelf-life, bacterial testing requirements, the efficacy of low-yield platelets, and managing a mixed platelet inventory. The decision to transition to pathogen-reduced platelets was associated with complex collection and processing limitations that resulted in either an increase in platelets that were over-concentrated or products with a low platelet yield.RESULTS: Through trials of various collection settings with unique target volumes and target platelet yields, our blood donor center was able to optimize the production. At the hospital end, this transition required a thorough review of low-yield platelet products and their clinical efficacy. Additionally, this implementation necessitated collaboration with clinical colleagues, comprehensive education, and training.CONCLUSIONS: Pathogen-reduced platelets would be the most efficient way for our institution to be compliant. This summary may serve as a roadmap for other institutions that are considering which FDA prescribed method to use and provide support for those that have decided on pathogen reduction technology but need to optimize their collections to best utilize low-yield products.

  View details for DOI 10.1111/trf.16744

  View details for PubMedID 34796968

• Blood Component Culturing Practices at an Academic Medical Center Transfusion Service Swenson, E. A., Kilambi, S., Shan, H. WILEY. 2021: 223A

  View details for Web of Science ID 000697116900336

• Current advances in transfusion medicine 2020: A critical review of selected topics by the AABB Clinical Transfusion Medicine Committee. Transfusion Allen, E. S., Cohn, C. S., Bakhtary, S., Dunbar, N. M., Gniadek, T., Hopkins, C. K., Jacobson, J., Lokhandwala, P. M., Metcalf, R. A., Murphy, C., Prochaska, M. T., Raval, J. S., Shan, H., Storch, E. K., Pagano, M. B. 2021

  Abstract

  BACKGROUND: The AABB Clinical Transfusion Medicine Committee (CTMC) compiles an annual synopsis of the published literature covering important developments in the field of transfusion medicine (TM), which has been made available as a manuscript published in Transfusion since 2018.METHODS: CTMC committee members reviewed original manuscripts including TM-related topics published electronically (ahead) or in print from December 2019 to December 2020. The selection of topics and manuscripts was discussed at committee meetings and chosen based on relevance and originality. Next, committee members worked in pairs to create a synopsis of each topic, which was then reviewed by two additional committee members. The first and senior authors of this manuscript assembled the final manuscript. Although this synopsis is extensive, it is not exhaustive, and some papers may have been excluded or missed.RESULTS: The following topics are included: COVID-19 effects on the blood supply and regulatory landscape, COVID convalescent plasma, adult transfusion practices, whole blood, molecular immunohematology, pediatric TM, cellular therapy, and apheresis medicine.CONCLUSIONS: This synopsis provides easy access to relevant topics and may be useful as an educational tool.

  View details for DOI 10.1111/trf.16625

  View details for PubMedID 34423446

• Active surveillance of serious adverse events following transfusion of COVID-19 convalescent plasma. Transfusion Swenson, E., Wong, L. K., Jhaveri, P., Weng, Y., Kappagoda, S., Pandey, S., Pritchard, A., Rogers, A., Ruoss, S., Subramanian, A., Shan, H., Hollenhorst, M. 2021

  Abstract

  The reported incidence of adverse reactions following Coronavirus disease 2019 (COVID-19) convalescent plasma (CCP) transfusion has generally been lower than expected based on the incidence of transfusion reactions that have been observed in studies of conventional plasma transfusion. This raises the concern for under-reporting of adverse events in studies of CCP that rely on passive surveillance strategies.Our institution implemented a protocol to actively identify possible adverse reactions to CCP transfusion. In addition, we retrospectively reviewed the charts of inpatients who received CCP at Stanford Hospital between May 13, 2020 and January 31, 2021. We determined the incidence of adverse events following CCP transfusion.A total of 49 patients received CCP. Seven patients (14%) had an increased supplemental oxygen requirement within 4 h of transfusion completion, including one patient who was intubated during the transfusion. An additional 11 patients (total of 18, 37%) had increased oxygen requirements within 24 h of transfusion, including 3 patients who were intubated. Six patients (12%) fulfilled criteria for transfusion-associated circulatory overload (TACO).Using an active surveillance strategy, we commonly observed adverse events following the transfusion of CCP to hospitalized patients. It was not possible to definitively determine whether or not these adverse events are related to CCP transfusion. TACO was likely over-diagnosed given overlap with the manifestations of COVID-19. Nevertheless, these results suggest that the potential adverse effects of CCP transfusion may be underestimated by reports from passive surveillance studies.

  View details for DOI 10.1111/trf.16711

  View details for PubMedID 34677830

• Development and Evaluation of a Novel RT-PCR System for Reliable and Rapid SARS-CoV-2 Screening of Blood Donations. Transfusion Li, M., Zhao, Y., Li, Y., Chen, X., Luo, D., Luo, M., Hou, J., Liu, J., Liu, H., Wang, H., Dong, Y., Zhang, L., Ji, M., Zhao, X., Wei, C., Li, W., Gao, J., Shan, H., Fu, X. 2020

  Abstract

  BACKGROUND: The ongoing outbreak of SARS-CoV-2 has caused great global concerns. In contrast to SARS, some SARS-CoV-2 infected people can be asymptomatic or only have mild non-specific symptoms. Furthermore, there is evidence that SARS-CoV-2 may be infectious during an asymptomatic incubation period. With the discovery that SARS-CoV-2 can be detected in plasma or serum, blood safety is worthy of consideration.STUDY DESIGN AND METHODS: We developed a NAT screening system for SARS-CoV-2 targeting nucleocapsid protein (N) and open reading frame 1ab (ORF 1ab) gene which could screen 5076 samples every 24hours. 2019-nCoV RNA standard was used to evaluate linearity of standard curves. Diagnostic sensitivity and reproducibility were evaluated using artificial SARS-CoV-2 virus. Specificity was evaluated with 61 other respiratory pathogens. Diagnostic performance was evaluated by testing 2 sputum and 9 oropharyngeal swab specimens. The RT-PCR assay was used to screen SARS-CoV-2 RNA in blood donors specimens collected during the outbreak of SARS-CoV-2 in Chengdu.RESULTS: LOD of the SARS-CoV-2 RT-PCR assay for N and ORF 1ab gene were 12.5 and 27.58 copies/mL, respectively. Intra-assay and inter-assay for SARS-CoV-2 RT-PCR assay based on Ct were acceptably low. No cross-reactivity was observed with other respiratory virus and bacterial isolates. The overall agreement value between SARS-CoV-2 RT-PCR assay and clinical diagnostic results were 100%. A total of 16287 blood specimens collected from blood donors during SARS-CoV-2 surveillance were tested negative.CONCLUSIONS: A high throughput NAT screening system was developed for SARS-CoV-2 screening of blood donations during the outbreak of SARS-CoV-2.

  View details for DOI 10.1111/trf.16049

  View details for PubMedID 32798248

• Vox Sanguinis International Forum on Transfusion Services about Response to COVID-19. Vox sanguinis Lozano, M., Yazer, M., Jackson, B., Pagano, M., Rahimi-Levene, N., Peer, V., Bueno, J., Jackson, R., Shan, H., Amorim, L., Lopez, M. E., Boquimpani, C., Sprogoe, U., Bruun, M., Titlestad, K., Rushford, K., Wood, E., McQuilten, Z., de Angelis, V., Delle Donne, M., Murphy, M., Staves, J., Cho, D., Nakamura, F., Hangaishi, A., Callum, J., Lin, Y., Moghaddam, M., Gharehbaghian, A. 2020

  Abstract

  Question 1 Demographics: a. Beer Yaakov, Israel. b. Large academic medical center. c. 956 beds. d. 9034 RBC units issued in 2019, approximately 9000. e. 4831 confirmed SARS-CoV-2 cases and 17 deaths (March 31, 2020, 12:40 pm, data from the Israeli Ministry of Health). f. 9,136,000 inhabitants. g. The spread of SARS-CoV-2 in Israel is still increasing, but as of yesterday the rate of increase is declining sharply (from almost 30% of samples tested per day at the peak to 12% yesterday).

  View details for DOI 10.1111/vox.12944

  View details for PubMedID 32403155

• Deployment of convalescent plasma for the prevention and treatment of COVID-19. The Journal of clinical investigation Bloch, E. M., Shoham, S., Casadevall, A., Sachais, B. S., Shaz, B., Winters, J. L., van Buskirk, C., Grossman, B. J., Joyner, M., Henderson, J. P., Pekosz, A., Lau, B., Wesolowski, A., Katz, L., Shan, H., Auwaerter, P. G., Thomas, D., Sullivan, D. J., Paneth, N., Gehrie, E., Spitalnik, S., Hod, E., Pollack, L., Nicholson, W. T., Pirofski, L., Bailey, J. A., Tobian, A. A. 2020

  Abstract

  Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), the cause of coronavirus disease (COVID-19), has spurred a global health crisis. To date, there are no proven options for prophylaxis for those who have been exposed to SARS-CoV-2, nor therapy for those who develop COVID-19. Immune (i.e. "convalescent") plasma refers to plasma that is collected from individuals, following resolution of infection and development of antibodies. Passive antibody administration through transfusion of convalescent plasma may offer the only short-term strategy to confer immediate immunity to susceptible individuals. There are numerous examples, where convalescent plasma has been used successfully as post-exposure prophylaxis and/or treatment of infectious diseases, including other outbreaks of coronaviruses (e.g., SARS-1, Middle East Respiratory Syndrome [MERS]). Convalescent plasma has also been used in the COVID-19 pandemic; limited data from China suggest clinical benefit, including radiological resolution, reduction in viral loads and improved survival. Globally, blood centers have robust infrastructure to undertake collections and construct inventories of convalescent plasma to meet the growing demand. Nonetheless, there are nuanced challenges, both regulatory and logistical, spanning donor eligibility, donor recruitment, collections and transfusion itself. Data from rigorously controlled clinical trials of convalescent plasma are also few, underscoring the need to evaluate its use objectively for a range of indications (e.g., prevention vs treatment) and patient populations (e.g., age, comorbid disease). We provide an overview of convalescent plasma, from evidence of benefit, regulatory considerations, logistical work flow and proposed clinical trials, as scale up is brought underway to mobilize this critical resource. .

  View details for DOI 10.1172/JCI138745

  View details for PubMedID 32254064

• Establishing a Satellite Transfusion Service Within an Academic Medical Center. American journal of clinical pathology Murphy, C. H., Lim, A. Y., Chua, L., Shan, H., Goodnough, L. T., Virk, M. S. 2020

  Abstract

  OBJECTIVES: Increasingly complex medical care requires specialized transfusion support close at hand. Hospital growth can necessitate expansion of blood bank services to new locations to ensure rapid delivery of blood products. We describe the opening of a new satellite transfusion service designed to serve the needs of a pediatric hospital.METHODS: Institutional transition teams and stakeholders collaborated to discuss options for providing blood at a new pediatric hospital. A staffed satellite transfusion service met the diverse needs of multiple services and was considered a compromise between a full new transfusion service and automated solutions.RESULTS: Initial challenges in establishing the laboratory included regulatory uncertainty and interactions between two hospitals' information technology services. Laboratory scientist staffing and actual use required adapting the satellite service to an emergency release-only model.CONCLUSIONS: A flexibly staffed satellite transfusion service met the most urgent needs of a pediatric hospital expansion. Review of implementation revealed potential process improvements for future expansions, including comprehensive routine and massive transfusion simulations. The challenges experienced in supplying staff and specialized blood products track with national trends. Other institutions may consider establishing a satellite transfusion service in the context of both increasingly sophisticated automated solutions and complex blood needs.

  View details for DOI 10.1093/ajcp/aqaa018

  View details for PubMedID 32157269

• Coagulopathy and Transfusion Ratios in Pediatric Trauma. The journal of trauma and acute care surgery Murphy, C., Spain, D. A., Shan, H. 2020

  Abstract

  BACKGROUND: Coagulopathy has been associated with poor outcomes in adult and pediatric trauma. Previous clinical trials have shown benefits with balanced transfusion ratios in trauma resuscitation in adults, but smaller retrospective studies have not established the same in pediatrics. We constructed a pediatric trauma database at a level one trauma center for analysis.METHODS: The institutional trauma registry was queried for all pediatric trauma activations from 2008 to 2018. Patient identifiers were used to identify laboratory data from the electronic data warehouse.RESULTS: 2769 pediatric trauma patients were identified with 1492 arriving direct from the scene. Of those with complete transport data available, 81% arrived within 60 minutes from time of injury. 52 patients were transfused in the first 24 hours, with 25 receiving greater than an estimated 40 ml/kg of blood products. No significant difference in ratios of red cell to plasma transfused at 24 hours was observed between patients surviving to discharge (1.4, 95% CI 1.0 to 1.6) and deceased (1.7, 95% CI 1.4 to 1.9) (P = 0.087).Among direct admissions, an abnormal prothrombin time (PT) or partial thromboplastin time (PTT) taken within 2 hours of arrival was significantly associated with in-hospital mortality (P = 0.003 and <0.001), but no significant associations were seen for abnormal fibrinogen or platelet counts. Red cell to plasma transfusion ratios were not significantly associated with length of stay or ventilator days (P = 0.74 and 0.28).CONCLUSIONS: There was no significant difference between transfusion ratios of surviving and deceased patients at 3- and 24-hour time points, including in a weight-adjusted highly transfused subgroup. Coagulopathy remains an important issue in pediatric trauma and may guide future multicenter studies in optimizing transfusion ratios in pediatric trauma.LEVEL OF EVIDENCE: Level III, retrospective comparative study.

  View details for DOI 10.1097/TA.0000000000002609

  View details for PubMedID 32044872

• Current advances in transfusion medicine: a 2019 review of selected topics from the AABB Clinical Transfusion Medicine Committee. Transfusion Pagano, M. B., Allen, E. S., Chou, S. T., Dunbar, N. M., Gniadek, T. n., Goel, R. n., Harm, S. K., Hopkins, C. K., Jacobson, J. n., Lokhandwala, P. M., Metcalf, R. A., Raval, J. S., Schwartz, J. n., Shan, H. n., Spinella, P. C., Storch, E. n., Cohn, C. S. 2020

  Abstract

  The AABB Clinical Transfusion Medicine Committee (CTMC) compiles an annual synopsis of the published literature covering important developments in the field of transfusion medicine (TM) for the board of director's review. This synopsis is now made available as a manuscript published in TRANSFUSION.CTMC committee members review original manuscripts including TM-related topics published in different journals between late 2018 and 2019. The selection of topics and manuscripts are discussed at committee meetings and are chosen based on relevance and originality. After the topics and manuscripts are selected, committee members work in pairs to create a synopsis of the topics, which is then reviewed by two committee members. The first and senior authors of this manuscript assembled the final manuscript. Although this synopsis is comprehensive, it is not exhaustive, and some papers may have been excluded or missed.The following topics are included: infectious risks to the blood supply, iron donor studies, pre-transfusion testing interference and genotyping, cold agglutinin disease (CAD), HLA alloimmunization in platelet transfusions, patient blood management, updates to TACO and TRALI definitions, pediatric TM, and advances in apheresis medicine.This synopsis provides easy access to relevant topics and may be useful as an educational tool.

  View details for DOI 10.1111/trf.15848

  View details for PubMedID 32472580

• Current risk factors for HIV infection among blood donors in seven Chinese regions. Transfusion Zeng, P. n., Liu, J. n., Zhang, C. n., Zhang, B. n., Liu, W. n., Huang, M. n., Ma, H. n., Zhao, Y. n., Guo, R. n., He, M. n., Liu, Y. n., Liao, D. n., Sullivan, M. n., Wang, J. n., Cai, W. n., Ness, P. n., Shan, H. n. 2020

  Abstract

  In China, there is a rising concern on the increasing trends of HIV infections in high-risk groups, who make blood donations that might potentially challenge the blood safety. Analyses on current risk factors for HIV infection among Chinese blood donors are urgently needed for developing effective strategies to defer high-risk donors and to warrant the safety of the blood supply.We recruited 313 HIV-positive and 762 HIV-negative donors from seven study sites in China and evaluated donor demographic characteristics, current medical and behavioral risk factors associated with HIV infection in a case-control survey. Univariable analyses examined the relationship between HIV infection and donor and donation characteristics, medical and behavioral risks, living conditions, and lifestyles. Multivariable logistic regression analyses evaluated the association between selected individual risks and HIV infection. Regression tree analysis was used to select covariates correlated with both HIV infection and individual risks and thus need to be controlled for in logistic regression models.Being a man who has sex with men was associated with the highest odds of HIV infection. Not using a condom, having sex with HIV-infected individuals, having sex partners with sexually transmitted diseases (STDs), having more than two concurrent sex partners, or having an STD were all associated with more than five times higher odds of having HIV. Having remunerated sex was associated with a 2.4 increased odds of having HIV infection.High-risk sexual behaviors were among the major risks for HIV infection among Chinese blood donors.

  View details for DOI 10.1111/trf.15659

  View details for PubMedID 31912898

• The genotype distribution, infection stage and drug resistance mutation profile of human immunodeficiency virus-1 among the infected blood donors from five Chinese blood centers, 2014-2017. PloS one Liang, S., Liu, Z., Wang, S., Liu, J., Shi, L., Mao, W., Liu, C., Wan, J., Zhu, L., Huang, M., Liu, Y., Wang, J., Ness, P., Shan, H., Zeng, P., He, M. 2020; 15 (12): e0243650

  Abstract

  Human immunodeficiency virus-1 (HIV-1) exhibits high diversity and complexity in China, challenging the disease surveillance and antiretroviral therapy. Between July 1, 2014 and January 30, 2017, we investigated the profiles of HIV-1 infection stages, genotype distribution and drug resistance mutations (DRMs) using plasma samples from HIV Western blot (WB) confirmed blood donors from five Chinese blood centers (Chongqing, Guangxi, Luoyang, Mianyang, and Urumqi). HIV pol regions consisted of whole protease and partial reverse transcriptase were genotyped and analyzed for DRMs. Lag-Avidity testing was performed to identify the infection stages. Of the 356 HIV-1 WB positive samples tested by Lag-avidity assay, 19.1% (68/356) were recent infections. Genotyping on 356 amplified sequences presented the subtype distributions as following: CRF07_BC (65.7%), CRF08_BC (7.3%), CRF01_AE (19.1%), B (4.2%), CRF55_01B (3.1%), CRF59_01B (0.3%) and CRF68_01B (0.3%). No significant difference in genotype distribution was observed between recent and long-term infections. 48 DRMs were identified from 43 samples, indicating a drug resistance prevalence of 12.1% (43/356), which include seven protease inhibitors (PIs) accessory DRMs (Q58E, L23I and I84M), two PIs major DRMs (M46I, M46L), seven nucleoside RT inhibitors DRMs (D67N, K70Q, K219R and M184L), and 32 non-nucleoside RT inhibitors DRMs (K103N, V179E, K238N, V179D, E138G, G190E, A98G, Y188D and E138A). In addition, we had also identified CRFs from the 01B subtype including CRF55_01B (3.1%), CRF59_01B (0.3%) and CRF68_01B (0.3%). As an important part of the continuous monitoring of HIV-1 circulating strains among blood donors, our findings were expected to contribute to the comprehensive AIDS control and development of proper diagnostics for HIV-1 in China.

  View details for DOI 10.1371/journal.pone.0243650

  View details for PubMedID 33347449

• Vox Sanguinis International Forum on Transfusion Services about Response to COVID-19. Vox sanguinis Yazer, M. H., Jackson, B. n., Pagano, M. n., Rahimi-Levene, N. n., Peer, V. n., Bueno, J. L., Jackson, R. P., Shan, H. n., Amorim-Filho, L. n., Lopes, M. E., Boquimpani, C. n., Sprogøe, U. n., Bruun, M. T., Titlestad, K. n., Rushford, K. n., Wood, E. M., McQuilten, Z. K., de Angelis, V. n., Delle Donne, M. n., Murphy, M. n., Staves, J. n., Cho, D. n., Nakamura, F. n., Hangaishi, A. n., Callum, J. n., Lin, Y. n., Mogaddam, M. n., Gharehbaghian, A. n., Lozano, M. n. 2020

  Abstract

  The novel coronavirus (SARS-Cov-2) that was first reported in Wuhan, China and provokes the COVID-19 disease has developed into a pandemic with hundreds of thousands of people infected. Many governments have enforced social isolation protocols on their citizens, which has led to the closure of many large public gatherings in order to limit the spread of the virus. These closures could reasonably be expected to affect blood collections, thereby presaging shortages of blood for transfusion. On the other hand, steps such as the postponement of elective surgeries and other non-urgent transfusions could mitigate against potential shortfalls in the blood supply.

  View details for DOI 10.1111/vox.12943

  View details for PubMedID 32384164

• Hepatitis C virus genotype/subtype distribution and evolution among Chinese blood donors: Revealing recent viral expansion. PloS one Zhang, Y. n., Gao, Z. n., Wang, S. n., Liu, J. n., Paul, N. n., He, T. n., Liu, C. n., Zhang, H. n., Lv, Y. n., Cao, R. n., Mao, W. n., Wan, J. n., Ma, H. n., Huang, M. n., Liu, Y. n., Wang, J. n., Liao, P. n., Zeng, P. n., He, M. n., Shan, H. n. 2020; 15 (7): e0235612

  Abstract

  Hepatitis C virus (HCV) genotype (GT) distribution in China shows significant geographical and demographic difference. As a routinely tested virus in Chinese blood bank systems, rare molecular epidemiology research in blood donors is reported. Our purpose is to investigate the HCV GT/subtypes distribution, phylogenetic analysis and population genetics in Chinese blood donors. Anti-HCV screen positive samples and donor demographics were collected. HCV Core and E1 gene fragments were amplified by RT-PCR, followed by sequencing and phylogenetic analysis to determine HCV GTs/subtypes using MEGA 7.0. The population genetics were performed using Arlequin v3.0 and Beast v1.10.4. SPSS Statistics 17.0 software was used to analyze the correlation between HCV GTs/subtypes distribution and demographic characteristics. 419 and 293 samples based on Core and E1 gene respectively were successfully amplified. HCV la, lb, 2a, 3a, 3b, 6a, 6e and 6n were found, and the corresponding proportions were 0.66% (3/455), 58.68% (267/455), 17.80% (81/455) and 5.05% (23/455), 3.52% (16/455), 12.31% (56/455), 0.88% (4/455) and 0.66% (3/455). Samples from Guangxi showed the most abundant genetic diversity with 8 subtypes were found. The number of haplotypes in HCV-1b is higher than 2a and 6a. The negative Tajima's D and Fu's Fs values of HCV-1b, 2a and 6a suggested the population expansion of those HCV subtypes. The distribution of HCV GT showed significant statistical difference by age and ethnicity. Conclusion: An abundance of HCV genetic diversity was found in Chinese blood donors with mainly 1b and then 2a subtype. There were significant geographical and demographic differences in HCV GTs/subtypes among Chinese blood donors. HCV subtype 1b has stronger viability and HCV subtype 6a has experienced significant expansion.

  View details for DOI 10.1371/journal.pone.0235612

  View details for PubMedID 32649673

• Emergency response to COVID-19 epidemic: One Chinese blood centre's experience. Transfusion medicine (Oxford, England) Hu, P. n., Kang, J. n., Li, Y. n., Li, X. n., Li, M. n., Deng, M. n., Zhao, Y. n., Tian, H. n., Li, R. n., Zhang, J. n., Xi, Y. n., Li, W. n., Gao, J. n., Shan, H. n., Fu, X. n. 2020

  Abstract

  The COVID-19 epidemic has caused a significant global social and economic impact since December 2019. The objective of this study was to demonstrate the emergency response of a Chinese blood centre on maintaining both the safety and the sufficiency of blood supply during large, emerging, infectious epidemics.Early on in the outbreak of COVID-19, the Chengdu Blood Center developed strategies and implemented a series of measures, including enhanced recruitment efforts, addition of new donation deferral criteria and notification after donation, optimisation of donor experience, development and implementation of a new coronavirus nucleic acid detection technology platform for blood screening and screening all donations for SARS-CoV-2 RNA to maximumly protect the safety of blood supply during a time of unclear risk.Starting on February 20, the immediate satisfaction rate of blood product orders in Chengdu city's clinical settings reached 100%, and there was no case of blood transfusion infection.The recent experience during the outbreak of SARS-CoV-2 reminded us that improvement in the areas of national and international collaborative programmes for dealing with blood availability and safety concerns during early stages of a disaster and regional and national mechanisms for timely communication with the general public on behalf of blood services should help to better prepare us for future disasters.

  View details for DOI 10.1111/tme.12719

  View details for PubMedID 33000534

• HIV prevalence and incidence estimates among blood donors in five regions in China. Transfusion Shi, L., Liu, Y., Wang, J., Zeng, P., Gao, Z., Wang, S., Fu, P., Liu, J., Mao, W., He, W., Ma, H., Huang, M., Wan, J., Liao, D., Brambilla, D., Sullivan, M., Zou, S., Ness, P., He, M., Shan, H., International Component of the NHLBI Recipient Epidemiology and Donor Evaluation Study-III (REDS-III) 2019

  Abstract

  BACKGROUND: Previous data, although scant, indicated that the incidence of HIV in China has increased over the past decade. There is a growing concern about the impact of the HIV epidemic on blood safety.METHODS AND MATERIALS: We used donation data from five geographically-disperse blood centers in 2013-2016 participating in the Recipient Epidemiology and Donor Evaluation Study-III (REDS-III) China program to estimate HIV prevalence and incidence among blood donors. Multivariable logistic regression model was used to examine factors associated with HIV infection in Chinese blood donors.RESULTS: The overall HIV prevalence among first-time donors from 2013 through 2016 was 68.04 per 100,000 donors (95% CI 61.68-74.40). The HIV incidence rate was estimated to be 37.93 per 100,000 person-years (95% CI 30.62-46.97) among first-time donors and 20.55 per 100,000 person-years (95% CI 16.95-24.91) among repeat donors. There was substantial variation in HIV prevalence and incidence rates across blood centers. Multivariable logistic regression results showed that among first-time donors, being male, older than 25years, minority ethnicity, less than college education, and certain occupations (commercial services, factory workers, retired, unemployed, or self-employed) were associated with positive HIV confirmatory testing results.CONCLUSION: HIV prevalence and incidence among blood donors remain low in the selected five regions in China; however, an increasing trend is observed at some blood centers. It is important to monitor HIV epidemiology in Chinese blood donors on a continuous basis, especially among populations and regions of higher risk.

  View details for DOI 10.1111/trf.15636

  View details for PubMedID 31845344

• Coagulopathy Is Associated With Increased Mortality and Transfusion Requirements in a Pediatric Trauma Database Murphy, C. H., Spain, D. A., Shan, H. WILEY. 2019: 203A–204A

  View details for Web of Science ID 000502826600481

• HCV Prevalence and Incidence Estimates in Chinese Blood Donors Fu, P., Lv, Y., Zhang, H., Liu, C., Wen, X., Ma, H., He, T., Liao, D., Liu, Y., Shan, H. WILEY. 2019: 67A–68A

  View details for Web of Science ID 000502826600147

• Reducing Length of Stay and Red Blood Cell Transfusion by Implementing an Anesthesia Anemia Management Clinic Yunce, M., Shan, H., Tho Pham, Panigrahi, A. WILEY. 2019: 208A

  View details for Web of Science ID 000502826600493

• Non-HLA Antibody-Mediated Rejection of Lung Transplant Masquerading Transfusion-Related Acute Lung Injury Yunce, M., Virk, M., Zhang, B. M., Mooney, K., Saleem, A., Shan, H. WILEY. 2019: 199A

  View details for Web of Science ID 000502826600470

• Do high-risk behavior deferrals work? How to make it better? Transfusion Pandey, S., Shan, H. 2019; 59 (7): 2180–83

  View details for DOI 10.1111/trf.15409

  View details for PubMedID 31268590

• Blood utilization in five Chinese hospitals shows low hemoglobin thresholds in medical patients. Transfusion Carson, J. L., Liu, Y., Ness, P., Zaccaro, D. J., Wu, B., Meng, C., Zeng, X., Qin, L., Huang, C., Zhou, X., Xiong, T., Li, J., Xing, J., Liao, Q., Zheng, Q., Zhang, X., Wang, J., Shan, H. 2019

  Abstract

  BACKGROUND: The number of red blood cell units transfused per capita in China is lower than in western countries and the reason(s) for the difference is unknown.STUDY DESIGN AND METHODS: We randomly chose 5050 transfused patients from five Chinese hospitals. We compared transfused cases to nontransfused controls matched for the same underlying diagnosis. We assessed the pretransfusion hemoglobin (Hb) trigger and other clinical characteristics associated with transfusion. After stratifying by underlying disease, we compared pretransfusion Hb level in Chinese hospitals to 12 US hospitals.RESULTS: In 5050 patients who received transfusion, the pretransfusion Hb levels were lower in medical (6.3g/dL) compared to surgical patients receiving transfusion postoperatively (8.1g/dL). In patients with nonsurgical diagnoses, the pretransfusion Hb was much lower than that in the United States; the difference in mean Hb level varied by underlying diagnosis from 0.4to 1.8g/dL. In case-control analysis of cases (n = 1356) compared to controls (n = 1201), the pretransfusion Hb showed the strongest association with transfusion. Compared to 10g/dL, the odds ratio (95% confidence interval) for pretransfusion Hb of 7 to 7.9g/dL was 37.7 (24.8-57.4).CONCLUSION: Transfusion triggers in five Chinese hospitals appear comparable to those in the United States for surgical patients; however, medical patients have lower pretransfusion Hb levels (approx. 6g/dL). Of the factors assessed, the pretransfusion Hb was most strongly associated with transfusion. The clinical impact of lower transfusion thresholds used in China is unknown.

  View details for DOI 10.1111/trf.15385

  View details for PubMedID 31150566

• Estimation of hepatitis B-positive rates in Chinese blood donors by combining predonation and postdonation screening results TRANSFUSION Gao, Z., Liu, J., Fu, P., Huang, M., Cao, R., Wen, X., Zhang, C., He, T., Mao, W., Liao, D., Ke, L., Yang, Y., He, M., Liu, Y., Wang, J., Dodd, R. Y., Ness, P., Shan, H. 2019; 59 (5): 1749–54

  View details for DOI 10.1111/trf.15158

  View details for Web of Science ID 000467578600021

• Probable transmission of hepatitis E virus (HEV) via transfusion in the United States TRANSFUSION Ticehurst, J. R., Pisanic, N., Forman, M. S., Ordak, C., Heaney, C. D., Ong, E., Linnen, J. M., Ness, P. M., Guo, N., Shan, H., Nelson, K. E. 2019; 59 (3): 1024–34

  View details for DOI 10.1111/trf.15140

  View details for Web of Science ID 000460471900019

• Estimation of hepatitisB-positive rates in Chinese blood donors by combining predonation and postdonation screening results. Transfusion Gao, Z., Liu, J., Fu, P., Huang, M., Cao, R., Wen, X., Zhang, C., He, T., Mao, W., Liao, D., Ke, L., Yang, Y., He, M., Liu, Y., Wang, J., Dodd, R. Y., Ness, P., Shan, H. 2019

  Abstract

  BACKGROUND: Chinese blood centers use Hepatitis B surface antigen (HBsAg) rapid test (RT) in pre-donation and two rounds of screening with different enzyme-linked immunosorbent assays in post-donation. Nucleic acid testing (NAT) on screening non-reactive (SC-) donations has been gradually implemented since 2010. Yet RT+ and SC-/NAT+ donors are seldom included in hepatitis B virus (HBV) positive rate estimates in Chinese blood donors.METHODS: We performed HBsAg neutralization test (NT) on whole blood (WB) with pre-donation RT+ results and post-donation screening reactive (SC+) samples from Mianyang and Chongqing in 2015. The annual totals of pre- and post-donation NT+ donors were combined with the annual totals of SC-/NAT+ donors to derive the estimated HBV positive rates.RESULT: In Mianyang and Chongqing, 59.4% and 68.2% of RT+ donors in Jan-Aug 2015 contributed for NT, 95.5% and 97.2% of which were NT+ respectively. In 2015, 422 and 667 donors from Mianyang and Chongqing respectively were HBsAg RT+, yielding estimated 403 and 648 pre-donation RT+/NT+ deferrals. 411 and 668 post-donation SC+ samples were NT tested from Mianyang and Chongqing, of which 249 and 323 were NT+ respectively. An estimated 63 donors in Mianyang and 88 donors in Chongqing were SC-/NAT+. The estimated HBV confirmed positive rate in blood donors are 1.59% in Mianyang and 1.01% in Chongqing.CONCLUSION: Pre-donation HBsAg RT effectively intercepts donations from HBV infected donors. Using NT confirmatory results from RT+, SC+ and SC-/NAT+ donors, this study provides a model for more accurate estimation for HBV positive rates in China.

  View details for PubMedID 30758046

• Probable transmission of hepatitis E virus (HEV) via transfusion in the United States. Transfusion Ticehurst, J. R., Pisanic, N., Forman, M. S., Ordak, C., Heaney, C. D., Ong, E., Linnen, J. M., Ness, P. M., Guo, N., Shan, H., Nelson, K. E. 2019

  Abstract

  BACKGROUND: Hepatitis E virus (HEV) can inapparently infect blood donors. To assess transfusion transmission of HEV in the United States, which has not been documented, a donor-recipient repository was evaluated.STUDY DESIGN AND METHODS: To identify donations that contained HEV RNA and were linked to patient-recipients with antibody evidence of HEV exposure, we assayed samples from the Retrovirus Epidemiology Donor Study (REDS) Allogeneic Donor and Recipient repository that represents 13,201 linked donations and 3384 transfused patients. Posttransfusion samples, determined to contain IgG anti-HEV by enzyme-linked immunosorbent assay, were reassayed along with corresponding pretransfusion samples for seroconversion (incident exposure) or at least fourfold IgG anti-HEV increase (reexposure). HEV-exposed patients were linked to donations in which HEV RNA was then detected by reverse-transcription quantitative polymerase chain reaction, confirmed by transcription-mediated amplification, and phylogenetically analyzed as subgenomic cDNA sequences.RESULTS: Among all patients, 19 of 1036 (1.8%) who had IgG anti-HEV before transfusion were reexposed; 40 of 2348 (1.7%) without pretransfusion IgG anti-HEV seroconverted. These 59 patients were linked to 257 donations, 1 of which was positive by reverse-transcription quantitative polymerase chain reaction and transcription-mediated amplification. Plasma from this donation contained 5.5 log IU/mL of HEV RNA that grouped with HEV genotype 3, clade 3abchij. The patient-recipient of RBCs from this donation had a greater than eightfold IgG increase; however, clinical data are unavailable.CONCLUSIONS: This is the first report of probable HEV transmission via transfusion in the United States, although it has been frequently observed in Europe and Japan. Additional data on the magnitude of the risk in the United States are needed.

  View details for PubMedID 30702157

• Evaluate performance of the Abbott chemiluminescent microparticle immunoassay assay for detection of syphilis infection in Chinese blood donors. Journal of clinical laboratory analysis Fu, P. n., Devare, S. n., Liu, J. F., Lv, X. T., Yin, P. n., Wu, B. T., Ke, L. n., Liu, Y. n., Shan, H. n. 2019: e23033

  Abstract

  To prevent Treponema Pallidum (TP) transmission from blood transfusion, enzyme-linked immunosorbent assay (EIA) for anti-TP has been widely used in routine blood donation screening in China for many years. The aim of this study was to evaluate the performance of the Abbott CMIA assay for detection of anti-TP in Chinese blood donors.A total of 2420 plasma samples, already routinely screened for anti-TP by two different EIAs, from four blood Centers were tested for anti-TP by Abbott CMIA. Subsequently, all samples with positive results by one or both EIAs and/or by Abbott CMIA were subjected to confirmatory testing (CT) using recombinant immunoblot assay (RIBA) or Treponema Pallidum particle agglutination assay (TPPA). TP infection was defined by a RIBA or TPPA positive.Compared with two EIAs strategy, Abbott CMIA showed a relatively best sensitivity as 98.80% (95% CI: 97.44%-100.16%) and a relatively best specificity as 99.58% (95% CI: 99.30%-99.85%), yielding the best consistency (99.49%) between anti-TP CT results with the highest κ value of .98.This is the first study to evaluate the performance of the Abbott CMIA assays for detection of syphilis in Chinese blood donors. Our results suggested that CMIA performed better than both EIAs, and implementation of CMIA replacing two different EIA reagents might help to further reduce the risk of transfusion-transmitted TP infection, decrease unnecessary blood waste and loss of blood donors.

  View details for DOI 10.1002/jcla.23033

  View details for PubMedID 31617243

• Hepatitis C virus prevalence and incidence estimates among Chinese blood donors. Transfusion Fu, P. n., Lv, Y. n., Zhang, H. n., Liu, C. n., Wen, X. n., Ma, H. n., He, T. n., Ke, L. n., Wu, B. n., Liu, J. n., He, M. n., Liao, D. n., Wang, J. n., Ness, P. n., Liu, Y. n., Shan, H. n. 2019

  Abstract

  Hepatitis C virus (HCV) is an important transfusion-transmitted virus with global significance. The objective of this study was to evaluate the HCV prevalence and incidence among Chinese blood donors from 2013 to 2016.Whole blood and apheresis platelet donations collected from five Chinese blood centers from June 1, 2013, to December 31, 2016, were screened in parallel by two different enzyme-linked immunosorbent assays for anti-HIV 1/2, hepatitis B surface antigen, anti-HCV, and syphilis. Screening-reactive samples were further confirmed by western blot. Confirmatory positive rates among first-time and repeat donors were used to estimate the prevalence and incidence rates. Multivariable logistic regression modeling was used to examine factors associated with HCV infection.A total of 1,276,544 donations were collected from five Chinese blood centers, of which an estimated 1203 were confirmed HCV positive. The overall HCV prevalence among first-time donors was 166.56 per 100,000 donors (95% confidence interval, 156.04-177.08). The HCV incidence rate was estimated to be 15.21 (95% confidence interval, 11.83-19.56) per 100,000 person-years among repeat donors. Multivariable logistic regression results showed that increased age, lower educational levels, ethnicity, and occupation were all important factors associated with HCV confirmatory status among first-time donors (p < 0.01).HCV infection is still an important concern for transfusion safety in China. Our findings indicate that continued strong efforts are needed to monitor and control the risk of transfusion-transmitted HCV infection in China. Moreover, to reduce unnecessary donor loss, HCV donor screening procedures should be improved by incorporating confirmatory testing into routine blood center operations.

  View details for DOI 10.1111/trf.15432

  View details for PubMedID 31271469

• HIV Molecular Surveillance in Chinese Blood Donors Liu, Z., Zeng, P., Gao, Z., Liu, Y., He, M., Liu, J., Liao, D., Wang, J., Ness, P. M., Shan, H. WILEY. 2018: 206A

  View details for Web of Science ID 000444475900499

• The infection staging and profile of genotypic distribution and drug resistance mutation among the human immunodeficiency virus-1 infected blood donors from five Chinese blood centers, 2012-2014 PLOS ONE Zeng, P., Liu, Y., He, M., Wang, J., Keating, S., Mao, W., Huang, M., Ma, H., He, W., Bi, X., Liao, D., Busch, M., Ness, P., Liu, J., Shan, H., NHLBI Recipient Epidemiology 2017; 12 (6): e0179328

  Abstract

  The increasing complexity and diversity of the human immunodeficiency virus-1 (HIV-1) infections challenge the disease control and anti-retrovirus treatment in China. The infection stages and molecular characteristics of HIV-1 from infected Chinese blood donors were examined to shed light on the HIV genotype distribution and the status of drug resistance mutations (DRMs) in the changing HIV epidemic in China. Western blot (WB) confirmed HIV-1 positive plasma samples were collected from blood donors at five Chinese blood centers from April 16, 2012, through June 30, 2014. The HIV infection stages were determined using the Lag-avidity assay. HIV Pol regions including whole protease and partial reverse transcriptase (RT) were amplified and sequenced to establish the profile of genotype distribution and drug resistance mutations (DRMs). Viral loads were determined using the ROCHE COBAS system. Of the 259 HIV-1 positive samples tested by the Lag-avidity assay, 23.6% (61/259) were identified as recent infections. A total of 205 amplified sequences displayed the following genotype distributions: circulating recombinant form (CRF) 07_BC (61.5%), CRF08_BC (8.3%), CRF01_AE (20%), B (6.3%), and 01B (3.9%). There was no significant difference in genotype distribution between recent and long-term infections. 31 DRMs were identified from 27 samples including four protease inhibitors (PIs) accessory DRMs, two PIs major DRMs (M46I), two nucleoside RT inhibitors DRMs (K219R and K70Q), and 23 nonnucleoside RT inhibitors DRMs. 27 samples had DRMs, yielding a drug resistance prevalence of 13.2% (27/205). Our findings provide important information for developing strategies for comprehensive HIV control and improving anti-retroviral treatment in China.

  View details for PubMedID 28622345

• A 30-year systematic review and meta-analysis of hepatitis B virus among blood donors in mainland China: revealing increase of new threats. Transfusion Gao, Z., Zhang, Y., Shan, H., Shi, L., Liu, J., Xu, M., Zeng, P., Liu, Y., He, M. 2017

  Abstract

  Although screening strategies have been routinely implemented in blood centers, the residual risk of transfusion-transmitted hepatitis B virus (HBV) still poses a public health concern in China. The aim of this study is to investigate the HBV blood screening reactive rate and to illustrate the demographics of the corresponding blood donors with revealing of heterogeneity between previous studies and discovering potentially negligent threats.Literature reporting the HBV screening reactive rate in Chinese blood donors was identified by systematic searching of four electronic databases. We followed the Preferred Reporting of Items for Systematic Reviews and Meta-Analyses guidelines, and data manipulation and statistical analyses were performed by Stata 12.0.Our results showed that the pooled postdonation screening reactive rate was 1.32% (95% confidence interval [CI], 1.28%-1.36%) with a significant variation from 3.93% (95% CI, 3.45%-4.40%) before 1998 to 1.22% (95% CI, 1.18%-1.27%) after 1998 when the Blood Donation Law was implemented. Importantly, the HBV screening reactive rates were significantly higher among replacement and planned donors than among individual voluntary donors.Our results indicated blood centers in China should recruit more individual and group voluntary donors and convert more eligible first-time donors into repeat donors to reduce the risk of transfusion-transmitted HBV.

  View details for DOI 10.1111/trf.14162

  View details for PubMedID 28543021

• The association of elevated alanine aminotransferase levels with hepatitis E virus infections among blood donors in China. Transfusion Wang, M., He, M., Wu, B., Ke, L., Han, T., Wang, J., Shan, H., Ness, P., Guo, N., Liu, Y., Nelson, K. E. 2017; 57 (2): 273-279

  Abstract

  Transfusion transmission of hepatitis E virus (HEV) is an emerging health risk, yet blood donors are rarely screened for this pathogen. Many blood centers instituted screening of blood donors for elevated levels of alanine aminotransferase (ALT) levels to prevent hepatitis C virus, which has continued in China. We evaluated whether elevated ALT levels were associated with HEV among blood donors in China.Blood samples were collected from 9069 qualified volunteer blood donors from four blood centers in China. A total of 5023 had elevated ALT levels, that is, more than 40 IU/L, and 4046 samples had normal ALT. We tested all the 9069 samples for anti-HEV immunoglobulin (Ig)M, anti-HEV IgG, and HEV antigen. Those who were positive for anti-HEV IgM or HEV antigen were tested individually for HEV RNA by polymerase chain reaction.The prevalence of anti-HEV IgG in donors with elevated ALT levels (33.3%) was higher than those with normal ALT (24.9%; p < 0.01). The prevalence of anti-HEV IgM was similar in donations with increased ALT (1.41%) and normal ALT (1.46%). More ALT-elevated donations were HEV antigen positive, 62 of 5023 (1.23%), than were ALT-normal donations, seven of 4046 (0.17%; p < 0.01). Six donors with elevated ALT levels and acute HEV infection markers (anti-HEV IgM or HEV antigen) were HEV RNA positive.Markers of active infection including HEV antigen and HEV RNA are significantly more common among donors with elevated ALT levels in China. These data support the fact that ALT testing of donors to HEV antigen or HEV RNA would have greater specificity and exclude fewer acceptable donors.

  View details for DOI 10.1111/trf.13991

  View details for PubMedID 28194856

• Transfusion Medicine in China Comes of Age. Transfusion medicine reviews Shi, L. n., Shan, H. n. 2017; 31 (2): 81–83

  View details for PubMedID 28089761

• Development and validation of a real-time reverse transcriptase PCR assay for sensitive detection of SFTSV. Journal of medical virology Zeng, P., Yang, Z., Bakkour, S., Wang, B., Qing, S., Wang, J., Chen, L., Busch, M., Shan, H., Liu, J., Lee, T. 2016

  Abstract

  Severe fever with thrombocytopenia syndrome bunyavirus (sftsv) is an emerging tick-borne rna virus recently identified as the pathogen that causes severe fever with thrombocytopenia syndrome (sfts) in china. the existing commercial nucleic acid testing (comnat) assay with a relatively high claimed limit of quantitative detection (loqd) is not capable of sensitive detection and quantitation of sftsv. Thus, a new real-time reverse transcriptase (rt)-pcr assay with improved sensitivity is needed for clinical diagnosis; it could also be used to screen blood donors if necessary.We developed a new sftsv rt-pcr nat assay (newnat). About 129 plasma samples from 93 suspected sfts patients with typical clinical symptoms were tested using an anti-sftsv total antibody elisa and both comnat and newnat. The test performance of the two nat assays was evaluated and compared.The newnat had a lower limit for quantitative testing compared to comnat. Twelve samples were comnat negative but newnat positive. Out of 35 suspected sfts patients who were comnat negative and anti-sftsv total antibody negative, four tested positive by the newnat assay and one of these four seroconverted within 2-4 days after testing newnat positive. A high correlation was observed between the cts of the newnat and comnat assays.The newnat assay was sensitive for quantitative detection of sftsv and may be applicable to clinical diagnosis and studies of the need for blood donor screening.

  View details for DOI 10.1002/jmv.24760

  View details for PubMedID 28036115

• Patient Blood Management: An International Perspective. Anesthesia and analgesia Eichbaum, Q., Murphy, M., Liu, Y., Kajja, I., Hajjar, L. A., Smit Sibinga, C. T., Shan, H. 2016; 123 (6): 1574-1581

  Abstract

  This article describes practices in patient blood management (PBM) in 4 countries on different continents that may provide insights for anesthesiologists and other physicians working in global settings. The article has its foundation in the proceedings of a session at the 2014 AABB annual meeting during which international experts from England, Uganda, China, and Brazil presented the programs and implementation strategies in PBM developed in their respective countries. To systematize the review and enhance the comparability between these countries on different continents, authors were requested to respond to the same set of 6 key questions with respect to their country's PBM program(s). Considerable variation exists between these country regions that is driven both by differences in health contexts and by disparities in resources. Comparing PBM strategies from low-, middle-, and high-income countries, as described in this article, allows them to learn bidirectionally from one another and to work toward implementing innovative and preferably evidence-based strategies for improvement. Sharing and distributing knowledge from such programs will ultimately also improve transfusion outcomes and patient safety.

  View details for PubMedID 27870740

• Patient Blood Management: An International Perspective ANESTHESIA AND ANALGESIA Eichbaum, Q., Murphy, M., Liu, Y., Kajja, I., Hajjar, L. A., Sibinga, C. T., Shan, H. 2016; 123 (6): 1574-1581

  Abstract

  This article describes practices in patient blood management (PBM) in 4 countries on different continents that may provide insights for anesthesiologists and other physicians working in global settings. The article has its foundation in the proceedings of a session at the 2014 AABB annual meeting during which international experts from England, Uganda, China, and Brazil presented the programs and implementation strategies in PBM developed in their respective countries. To systematize the review and enhance the comparability between these countries on different continents, authors were requested to respond to the same set of 6 key questions with respect to their country's PBM program(s). Considerable variation exists between these country regions that is driven both by differences in health contexts and by disparities in resources. Comparing PBM strategies from low-, middle-, and high-income countries, as described in this article, allows them to learn bidirectionally from one another and to work toward implementing innovative and preferably evidence-based strategies for improvement. Sharing and distributing knowledge from such programs will ultimately also improve transfusion outcomes and patient safety.

  View details for DOI 10.1213/ANE.0000000000001597

  View details for Web of Science ID 000388144000029

• The power of collaboration. Transfusion Liu, J. n., Shan, H. n. 2016; 56 (12): 2910–12

  View details for PubMedID 27933626