- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00023023
Study of Transfusion-Transmitted Infections
A Prospective Study of Transfusion-Transmitted Infections
This study will follow blood transfusion recipients for 6 to 9 months following transfusion to monitor the quality and safety of blood transfusion. Improved viral testing and careful donor screening in the last several years has dramatically reduced the rates of transfusion-related HIV and hepatitis. Nevertheless, ongoing surveillance of transfusion-related infections is essential to maintain a high safety standard and to determine the transfusion risk of other infectious agents, such as cytomegalovirus, Epstein-Barr virus, parvovirus B-19, HHV-8 (Kaposi s sarcoma virus) and other possible hepatitis viruses that might be blood-transmitted. Transfused patients blood will be tested for various infectious agents. Their blood samples and blood samples from their donors will be frozen and stored in a repository so that any new infectious agent can be rapidly evaluated for its danger to the safety of the blood supply.
Adult patients at the National Institutes of Health and children at the Children s National Medical Center who are scheduled to receive a blood transfusion or to undergo surgery for which a blood transfusion may be needed are eligible for this study.
All participants will have a 20- to 25-milliliter (about 2 tablespoonfuls) blood sample drawn before their transfusion and again at 1, 2, 4, 12 and 24 weeks after the transfusion. Patients who are transfused on more than one occasion over the course of the study will provide three additional monthly samples. Patients who develop a transfusion-transmitted infection during the study will provide up to four more samples to study the infection and its effects. Participants will complete a brief questionnaire at the end of the study regarding prior blood transfusions and the development of any illnesses, such as hepatitis, that might have been caused by the transfusion.
Study Overview
Status
Detailed Description
Improved viral screening assays and more intensive questioning of donors for high-risk behaviors have resulted in dramatic declines in the rates of transfusion-transmitted hepatitis and AIDS. Nonetheless, there is need for continued vigilance of the safety of blood supply. This study will enroll blood donors and prospectively followed blood recipients in order to: 1) establish ongoing surveillance of the incidence of breakthrough infections from transfusion-transmitted agents for which there are existing donor-screening assays (e.g. HBV, HCV, HIV, human T cell lymphotropic virus [HTLV]); 2) monitor the transfusion risk of established infectious agents that are not routinely screened in blood donors including CMV, parvovirus B-19, and HHV-8 [Kaposi's sarcoma virus]; 3) establish a repository of linked donor and recipient samples so that any newly emerging infectious agent can be rapidly evaluated for its threat to the blood supply.
The risk of these blood transmitted infectious agents will be assessed by molecular and serologic assays in adult patients at NIH and Suburban Hospital in children at Children's National Medical Center. Blood samples from recipients transfused on one occasion will be obtained pre-transfusion and 1, 2, 4, 12, and 24 weeks post-transfusion. Recurrently transfused patients will have additional samples at 16 and 20 weeks after the index transfusion and 24 weeks after the last eligible transfusion. After initial infectious disease testing, recipient samples and linked donor samples will be stored in an off-site biorepository. The availability of the repository will allow for the assessment of transfusion risk for newly emerging pathogens and also for known agents for which there is no practical assay currently available. For example, this would allow future testing for prions in new variant Creutzfeld-Jacob disease (human variant of mad cow disease) or testing for the trypanosome that causes Chagas disease. Informed consent will be obtained to store and later test samples in the repository. Testing will be limited to infectious agents that potentially threaten the blood supply. No genetic testing will be performed.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Childrens National Medical Center
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center
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Bethesda, Maryland, United States, 20814
- NIH Heart Center at Suburban Hospital Johns Hopkins Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- INCLUSION CRITERIA
All adult (greater than or equal to 18 years) patients who are transfused at NIH will be eligible if:
- they have not been transfused in the 6 weeks preceding the index transfusion;
- they are expected to remain in the continental USA for at least six months post the index transfusion; and
- if they are consented and a pre-sample is obtained
- if they receive a transfusion during their NIH stay
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Adults and children subjects
The NIH and SH components will enroll and follow only adult (age >=18) blood donor or recipient subjects.
CNMC will enroll and follow children between the ages of 6 months and 18 years.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive viral DNA or RNA result
Time Frame: 1, 2, and 4 wk post-Txn
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Patients tests positive for any number of viral RNA/DNA which could infer transfusion-transmission.
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1, 2, and 4 wk post-Txn
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Positive viral antibody result
Time Frame: 12, 24 and/or 6mo
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Patients tests positive for any number of viral antibodies which could infer transfusion-transmission.
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12, 24 and/or 6mo
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Viral discovery
Time Frame: 1, 2, and 4 wk and 12, 24 and/or 6mo
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Pre- and post- transfusion samples can be used for viral discovery programs employing GWAS, full genome sequencing or other methods that may evolve.
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1, 2, and 4 wk and 12, 24 and/or 6mo
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Collaborators and Investigators
Investigators
- Principal Investigator: Valeria De Giorgi, Ph.D., National Institutes of Health Clinical Center (CC)
Publications and helpful links
General Publications
- Schreiber GB, Busch MP, Kleinman SH, Korelitz JJ. The risk of transfusion-transmitted viral infections. The Retrovirus Epidemiology Donor Study. N Engl J Med. 1996 Jun 27;334(26):1685-90. doi: 10.1056/NEJM199606273342601.
- Kleinman S, Busch MP, Korelitz JJ, Schreiber GB. The incidence/window period model and its use to assess the risk of transfusion-transmitted human immunodeficiency virus and hepatitis C virus infection. Transfus Med Rev. 1997 Jul;11(3):155-72. doi: 10.1053/tmrv.1997.0110155. No abstract available.
- Alter HJ, Houghton M. Clinical Medical Research Award. Hepatitis C virus and eliminating post-transfusion hepatitis. Nat Med. 2000 Oct;6(10):1082-6. doi: 10.1038/80394. No abstract available.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 010231
- 01-CC-0231
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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