(Verbatim from the application): A prospective study of pediatric transfusion recipients will be conducted to determine the residual risk of transmitting known infectious agents such as hepatitis viruses, HIV and HTLV, for which there are current donor screening assays, and the potential risk of known agents that are not routinely screened during blood donation, but might, nonetheless, infect blood recipients with diseases such as cytomegalovirus, parvovirus B-19, human herpes virus-8 (HHV-8) and newly proposed hepatitis viruses, TTV and SEN-V. An additional primary goal of the study will be to establish a repository of linked donor and recipient samples so that if a new infectious agent emerges in the future, testing of the repository will rapidly establish whether or not that agent presents a threat to the blood supply. To insure larger numbers of samples and greater statistical power, samples from this study will be merged into a large repository to be generated in the NHLBI-sponsored RADAR (REDS Allogeneic Donor and Recipient) study. The current study will be the only pediatric arm of the RADAR multi-center study. Further, the current pediatric study will be undertaken collaboratively with a similarly designed study in adults being conducted at the NIH Clinical Center. In both studies recipients will be enrolled prior to transfusion and then followed for at least 6 months post-transfusion. Blood samples will be obtained before and at 2, 4, 8, 12, 16 and 24 weeks after transfusion. Molecular and serologic testing will be routinely performed for the agents cited above with particular emphasis on molecular assays for HRV, HCV. HIV, SEN-V, CMV, parvovirus B-i 9 and HHV-8. Aliquots will be retained in frozen storage. In addition, pre and post-transfusion and donor whole blood samples will be frozen to allow for recovery of recipient DNA and identification of microchimerism. Such microchimerism may result in transfusion-associated graft versus host disease and immunosuppression and have long term consequences for the development of immune mediated diseases in the recipient. In summary, the primary pediatric study and the proposed collaborations will allow for determinations of the transfusion risk of a variety of blood-screened and unscreened infectious agents, and will allow for comparisons of transfusion risk between pediatric and adult patients, as well as comparisons of viral persistence and clinical outcome according to age. In addition, by contributing pre and post-transfusion samples from blood recipients and their linked donor samples, this study will help establish a large serum and cell repository that will allow for the future determination of whether virtually any infectious agent is transfusion-transmitted and a potential risk to blood recipients.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project (R01)
Project #
5R01HL067229-05
Application #
6860042
Study Section
Special Emphasis Panel (ZRG1-CCVS (01))
Program Officer
Barbosa, Luiz H
Project Start
2001-04-10
Project End
2007-07-31
Budget Start
2005-04-01
Budget End
2007-07-31
Support Year
5
Fiscal Year
2005
Total Cost
$334,750
Indirect Cost
Name
Children's Research Institute
Department
Type
DUNS #
143983562
City
Washington
State
DC
Country
United States
Zip Code
20010
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Xu, Chenyu; Wang, Richard Y; Schechterly, Cathy A et al. (2013) An assessment of hepatitis E virus (HEV) in US blood donors and recipients: no detectable HEV RNA in 1939 donors tested and no evidence for HEV transmission to 362 prospectively followed recipients. Transfusion 53:2505-11
Sanchez, Rosa; Lee, Tzong-Hae; Wen, Li et al. (2012) Absence of transfusion-associated microchimerism in pediatric and adult recipients of leukoreduced and gamma-irradiated blood components. Transfusion 52:936-45
Luban, Naomi L C; McBride, Eileen; Ford, Jason C et al. (2012) Transfusion medicine problems and solutions for the pediatric hematologist/oncologist. Pediatr Blood Cancer 58:1106-11
Yu, Mei-Ying W; Alter, Harvey J; Virata-Theimer, Maria Luisa A et al. (2010) Parvovirus B19 infection transmitted by transfusion of red blood cells confirmed by molecular analysis of linked donor and recipient samples. Transfusion 50:1712-21
Wong, Edward C C; Perez-Albuerne, Evelio; Moscow, Jeffrey A et al. (2005) Transfusion management strategies: a survey of practicing pediatric hematology/oncology specialists. Pediatr Blood Cancer 44:119-27
Luban, Naomi L C (2002) Neonatal red blood cell transfusions. Curr Opin Hematol 9:533-6