1 / 25

Global Transfusion Safety Research and Training

Global Transfusion Safety Research and Training. Global Healing / ABC Meeting Washington DC March 14, 2013. Outline & Credits. REDS-III International NHLBI funded multicenter study Africa Quality Control study Francophone network: JJ Lefrere, S Laperche

trula
Download Presentation

Global Transfusion Safety Research and Training

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Global Transfusion Safety Research and Training Global Healing / ABC Meeting Washington DC March 14, 2013

  2. Outline & Credits • REDS-III International • NHLBI funded multicenter study • Africa Quality Control study • Francophone network: JJ Lefrere, S Laperche • Anglophone network: E Bloch, EL Murphy • Global Research Training program • Latin America • Institut Pasteur (francophone Africa) • South Africa (anglophone Africa)

  3. South African National Blood Service (SANBS) • >780,000 annual donations in 7 regions • Centralized ID testing in two major laboratories (Johannesburg & Durban) • Single operational IT system and national data warehouse • Operates in-hospital dispensing units

  4. Needs Assessment – South Africa • South Africa has the highest HIV prevalence and incidence in the world • High blood utilization in obstetric setting and for HIV disease • Imbalance in blood collection between minority White (63% blood) and majority Black (24% of blood) population poses problems

  5. SANBS HIV Prevalence

  6. SANBS NAT Yield Year 1 – 10/05-9/06 Year 2 – 10/06-9/07 2 (0.27%) anti-HIV+ HIV RNA- 11 (1.1%) Anti-HIV+ HIV RNA- 716 HIV RNA+ Anti-HIV+ 956 HIV RNA+ Anti-HIV+ 30 (3%) HIV RNA+ Anti-HIV- 16 (2.1%) HIV RNA+ anti-HIV- 9 (0.5%) HIV RNA- Anti-HIV+ Year 4 – 10/08-9/09 Year 3 – 10/07-9/08 1624 HIV RNA+ Anti-HIV+ 1297 HIV RNA+ Anti-HIV+ 8 (0.6%) HIV RNA- Anti-HIV+ 41 (2.4%) HIV RNA+ Anti-HIV- 35 (2.6%) HCV RNA+ Anti-HCV-

  7. The NHLBI Recipient Epidemiology and Donor Evaluation Study (REDS-III) • Goal of the REDS-III research program is to improve the safety and availability of transfused blood products in the U.S. and internationally. • Seven year multicenter program with international and domestic components, charged with addressing scientific research priorities in blood banking and transfusion medicine. • Education and training component • A cohesive, global, and dynamic program.

  8. REDS-III Structure Hospitals U.S. Blood Centers USA-Foreign Partnerships NHLBI H Yale/New England ARC Brazil H H ITxM Pittsburgh Data Coord. Center (RTI) China H H Blood Center of Wisconsin South Africa H Central Lab (BSRI) H UCSF/BSRI San Francisco H

  9. REDS-III South Africa Program • The University of California San Francisco (UCSF) and the South African National Blood Service (SANBS) • On-going phase 1 (3/2011-3/2013) studies: • Pilot Obstetric hemorrhage project to evaluate feasibility of collecting data on obstetric hemorrhage and HIV infection among pregnant women and prevention of mother to child transmission • Standardizing staging and molecular characterization of HIV-1 strains in the three REDS-III International programs (Brazil, China, and South Africa) to assure optimal detection of incident infections and classification of genotypes/circulating recombinant forms (CRFs), drug resistance profiles, and detailed characterization of transmitted/founder viruses • Proposed phase 2 (4/2013-3/2017) studies: • Incident HIV and incident HBV infections in South African blood donors: behavioral risk factors, genotypes and biological characterization of early infections • Transfusion for obstetric hemorrhage in South Africa: impact on HIV disease progression and other infections • Blood donor recruitment and retention in South Africa

  10. REDS-III Brazil Program • The Blood Systems Research Institute and the FundacaoFaculdade de Medicina and Hospital das Clinicas of the Medical School of the University of Sao Paulo with participation of 4 blood centers located in Bello Horizonte - Minas Gerais (FundacaoHemominas), Recife - Pernambuco (FundacaoHemope), Sao Paolo (Fundacao Pro-Sangue), and Rio de Janeiro (Fundacao Hemorio) International Brazil Program • On-going phase 1 (3/2011-3/2013) studies • The dengue virus incidence and prevalence in Brazilian donors and recipients: Evaluating rates and correlates of transfusion‐transmission, and clinical outcomes of infection in recipients • Standardizing staging and molecular characterization of HIV-1 strains in the three REDS-III International programs (Brazil, China, and South Africa) to assure optimal detection of incident infections and classification of genotypes/circulating recombinant forms (CRFs), drug resistance profiles, and detailed characterization of transmitted/founder viruses • Proposed phase 2 (4/2013-3/2017) studies • Prevalence, incidence, epidemiology and molecular variants of HIV in blood donors in Brazil • Establishing a sickle cell disease cohort and identifying molecular determinants of response to transfusions, genetic determinants of alloimmunization, and prevalence of HIV and other transfusion-transmitted infections • Chagas disease progression - follow-up visit of the Chagas disease cohort established during REDS-II Brazil • Improving the safety of blood donation in Brazil through an assessment of the effectiveness of HIV notification and counseling, and linkage of HIV positive donors to healthcare

  11. REDS-III China Program • The Johns Hopkins University and the Chinese Institute of Blood Transfusion with participation of 5 blood centers located in Kunming, Urumqi, Luoyang, Liuzhou, and Mianyang • On-going phase 1 (3/2011-3/2013) studies • A study of Severe Fever with Thrombocytopenia Syndrome Virus (SFTSV ) seroprevalence and rates of asymptomatic viremia in Chinese blood donors from four Chinese regions • Standardizing staging and molecular characterization of HIV-1 strains in the three REDS-III International programs (Brazil, China, and South Africa) to assure optimal detection of incident infections and classification of genotypes/circulating recombinant forms (CRFs), drug resistance profiles, and detailed characterization of transmitted/founder viruses • Proposed phase 2 (4/2013-3/2017) studies • HIV study in Chinese blood donors, including incidence/prevalence, molecular epidemiology and risk factor analysis • Blood utilization study in five Chinese hospitals to determine the clinical settings, frequency and indications for red blood cell transfusion

  12. 2nd Quality Control in Francophone Africa, 2010 17 participating countries- 51 labs- 60 panels tested Marocco 4 labs 4 panels Tunisia 3 labs 4 panels Mali 3 labs 3 panels Burkina Faso 5 labs 5 panels Niger 3 labs 3 panels Senegal 4 labs 4 panels DemocraticRepublic of Congo 2 labs 2 panels Guinea 1 lab 1 panel Rwanda 2 labs 2 panels IvoryCoast 2 labs 2 panels Burundi 1 lab 5 panels Benin 1 lab 4 panels Togo 2 labs 2 panels Comoros 1 lab 1 panels Cameroun 4 labs 4 panels Madagascar 7 labs 7 panels Congo Brazaville 7 labs 7 panels

  13. Test Type vs. Sensitivity (unadjusted)

  14. Blue = Prior study in Francophone Africa Red = New APTS Final Map 17countries approached Final Count 12countries 44 centers Botswana (n=2 centers) Cape Verde (n=2) Ghana (n=3) Kenya (n=9) Lesotho (n=1) Mauritius (n=1) Nigeria (n=7) South Africa (n=3) Tanzania (n=7) Uganda (n=6) Zambia (n=2) Zimbabwe (n=1)

  15. The Participating Centers

  16. Summary Results • SensitivityTrue Positive • SpecificityTrue Negative • Quality Score (Accuracy)Positive and Negative results

  17. HIV

  18. HBV

  19. HCV

  20. 2nd Quality Control in Francophone Africa, 2010 Results (1)

  21. Global Transfusion Research Training Who: Younger MD’s, PhD’s or senior technicians, research interest and leadership potential What: 1) state-of-the-art review of research in blood donor selection and laboratory testing; and 2) practical training in epidemiology and clinical research methods; 3) protocol writing workshop Where: In-country How long: 2 weeks

  22. Curriculum Morning Lectures: • Principles of clinical research and Tx Medicine • Follows the textbook: Hulley SB et al. Designing Clinical Research (3rd edition), 2007. Afternoon Workshops: • Each trainee must bring to the course a research question relevant to his/her local blood bank. • Each afternoon, the trainee builds a new section of a 5-6 page research protocol • After the course, the trainee is encouraged to accomplish his/her project

  23. * Institut Pasteur; trainees from Francophone Africa

  24. Transfusion TICR Publications Goncalez TT, Sabino EC, Murphy EL, Chen S, Chamone DA, McFarland W. Human immunodeficiency virus test-seeking motivation in blood donors, Sao Paulo, Brazil. Vox Sang 2006;90:170-6. de Almeida Neto C, McFarland W, Murphy EL, Chen S, Nogueira FA, Mendrone A Jr, Salles NA, Chamone DA, Sabino EC. Risk factors for human immunodeficiency virus infection among blood donors in Sao Paulo, Brazil, and their relevance to current donor deferral criteria. Transfusion 2007;47:608-14. Goncalez TT, Sabino EC, Chen S, Salles NA, Chamone DA, McFarland W, Murphy EL. Knowledge, Attitudes and Motivations Among Blood Donors in São Paulo, Brazil. AIDS Behav 2008;12(4 suppl):S39-47. Epub 2008 Apr 4. Almeida Neto C, Murphy EL, McFarland W, Mendrone Junior A, Chen S, Chamone DAF, Sabino EC. Changes in the profile of blood donors with reactive serologic tests for syphilis in Sao Paulo, Brazil and its relevance to blood bank practice. Transfusion 2009;49:330-6. Tagny CT, Diarra A, Yahaya R, Hakizimana M, Nguessan A, Mbensa G, Nebie Y, Dahourou H, Mbanya D, Shiboski C, Murphy E, Lefrere JJ. Characteristics of blood donors and donated blood in sub-Saharan Francophone Africa. Transfusion 2009 Mar 10. Laperche S, Boukatou G, Kouegnigan L, Nébié Y, Boulahi MO, Tagny CT, Yahaya R, Tapko JB, Murphy E, Lefrère JJ. Transfusion safety on the African continent: an international quality control of virus testing in blood banks. Transfusion 2009 Jun 10. Jagannathan L, Rice M, Chaturvedi M, Murphy EL et al. Risk factors for chronic hepatitis B virus infection among Indian blood donors. Transfusion Med 2010; 20:414-420.

  25. Acknowledgements • REDS-III International • NHLBI Research Contracts • Africa QC study • BSRI funding • Global Research Training • Blood Systems Research Institute • NHLBI K24-HL-075036 (Murphy) • InstitutPasteur • Industry • Chiron/Novartis • International Society of Blood Transfusion • UCSF Center for AIDS Research • Brazilian Ministry of Health

More Related