Viewing Study NCT00029406



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Last Modification Date: 2024-10-26 @ 9:07 AM
Study NCT ID: NCT00029406
Status: COMPLETED
Last Update Posted: 2015-12-16
First Post: 2002-01-10

Brief Title: Transfusion Infections Pediatric Prospective Study TRIPPS
Sponsor: Naomi Luban
Organization: Childrens National Research Institute

Study Overview

Official Title: Transfusion Infections Pediatric Prospective Study TRIPPS
Status: COMPLETED
Status Verified Date: 2015-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: TRIPPS
Brief Summary: To conduct a prospective study of pediatric transfusion recipients to determine the risk of transmitting various infectious agents by blood transfusion
Detailed Description: 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01HL067229 NIH None httpsreporternihgovquickSearchR01HL067229