Transfusion Infections Pediatric Prospective Study (TRIPPS)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Research Institute
ClinicalTrials.gov Identifier:
NCT00029406
First received: January 10, 2002
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transfusion Infections Pediatric Prospective Study (TRIPPS)

Resource links provided by NLM:


Further study details as provided by Children's Research Institute:

Primary Outcome Measures:
  • Rates of transfusion-transmitted viruses [ Time Frame: 6 months post-transfusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prevalence of newly emerging transfusion-transmitted viruses in blood donors [ Time Frame: 6 months post-transfusion ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Whole blood and plasma samples


Enrollment: 600
Study Start Date: April 2001
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   6 Months to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pediatric recipients of allogeneic blood transfusion and linked blood donors

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00029406

Sponsors and Collaborators
Children's Research Institute
Investigators
Principal Investigator: Naomi Luban Children's Research Institute
  More Information

Publications:
Responsible Party: Children's Research Institute
ClinicalTrials.gov Identifier: NCT00029406     History of Changes
Other Study ID Numbers: 990, R01HL067229
Study First Received: January 10, 2002
Last Updated: June 5, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Cytomegalovirus Infections
Hepatitis
Hepatitis A
Hepatitis, Viral, Human
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Liver Diseases
Digestive System Diseases
Enterovirus Infections
Picornaviridae Infections

ClinicalTrials.gov processed this record on August 25, 2014