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Transfusion Infections Pediatric Prospective Study (TRIPPS) (TRIPPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00029406
Recruitment Status : Completed
First Posted : January 11, 2002
Last Update Posted : December 16, 2015
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Naomi Luban, Children's National Research Institute

Brief Summary:
To conduct a prospective study of pediatric transfusion recipients to determine the risk of transmitting various infectious agents by blood transfusion.

Condition or disease
Blood Donors Blood Transfusion Cytomegalovirus Infections Hepatitis, Viral, Human HIV Infections

Detailed Description:


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.


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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Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transfusion Infections Pediatric Prospective Study (TRIPPS)
Study Start Date : April 2001
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Rates of transfusion-transmitted viruses [ Time Frame: 6 months post-transfusion ]

Secondary Outcome Measures :
  1. Prevalence of newly emerging transfusion-transmitted viruses in blood donors [ Time Frame: 6 months post-transfusion ]

Biospecimen Retention:   Samples Without DNA
Whole blood and plasma samples

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pediatric recipients of allogeneic blood transfusion and linked blood donors

Inclusion Criteria:

  • Pediatric cardiac, orthopedic, and neurosurgery patients
  • Trauma patients who are transfused
  • Sickle cell patients who are sporadically transfused
  • No allogeneic transfusion in the 6 weeks preceding the index transfusion
  • A pre-transfusion sample is available from the recipient
  • Life expectancy greater than 6 months
  • Residence in the continental US

Exclusion Criteria:

  • History of allogeneic blood transfusion in the prior three months
  • Currently pregnant
  • Patients on dialysis
  • Patients with conditions causing significant immunosuppression

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00029406

Sponsors and Collaborators
Naomi Luban
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Naomi Luban Children's National Research Institute
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Responsible Party: Naomi Luban, MD, Children's National Research Institute Identifier: NCT00029406    
Other Study ID Numbers: 990
R01HL067229 ( U.S. NIH Grant/Contract )
First Posted: January 11, 2002    Key Record Dates
Last Update Posted: December 16, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Communicable Diseases
Cytomegalovirus Infections
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Herpesviridae Infections
DNA Virus Infections