HIV Infections Clinical Trial
Official title:
Transfusion Infections Pediatric Prospective Study (TRIPPS)
To conduct a prospective study of pediatric transfusion recipients to determine the risk of transmitting various infectious agents by blood transfusion.
BACKGROUND:
Despite a marked reduction in the risk of transfusion-transmitted disease, lessons learned
from the delayed recognition of HIV transmission by transfusion, underscore the necessity
for continued vigilance for blood safety. The study will correct a significant lack of
prospective studies of transfusion transmitted disease in infants and children in this
country. A critical material outcome of the study will be the establishment of a large serum
and cell repository of linked patient recipient samples. Such a repository, representing
prospective studies in a pediatric population, will be unique. It will provide a means for
ongoing surveillance to identify more rapidly emerging infectious agents and to aid in
determining whether they present a significant risk to the blood supply. Because of a close
collaboration and parallel structure with two related adult transfusion studies, age related
comparisons of viral clearance and clinical outcomes should likewise be derived from this
work.
DESIGN NARRATIVE:
The prospective study of pediatric transfusion recipients will determine the residual risk
of transmitting known infectious agents such as hepatitis viruses, human immunodeficiency
virus (HIV) and human T-cell leukemia virus (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 the SEN virus (SEN-V). An additional primary goal of the study is 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 human retroviruses (HRV), hepatitis C virus (HCV). HIV, SEN-V, cytomegalovirus (CMV),
parvovirus B-i 9 and human herpesvirus-8 (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.
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Observational Model: Cohort, Time Perspective: Prospective
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