Clinical trial NCT00023023: Study of Transfusion-Transmitted Infections
Official title: A Prospective Study of Transfusion-Transmitted Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Viral Disease
Blood Donation
Transfusion-Transmitted Infections
Keywords: Hepatitis
Blood Bank
Viruses
Blood Donors
Blood Recipients
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2001-08-20
Enrollment: 1771
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Under an established collaborative agreement and IRB authorization agreement between NIH and Suburban Hospital/Johns Hopkins Health System (JHHS), TRIPS will enroll patients undergoing open heart surgery at SH.

Brief summary: 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.

...

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.

Eligibility criteria: * INCLUSION CRITERIA

All adult (greater than or equal to 18 years) patients who are transfused at NIH will be eligible if:

1. they have not been transfused in the 6 weeks preceding the index transfusion;
2. they are expected to remain in the continental USA for at least six months post the index transfusion; and
3. if they are consented and a pre-sample is obtained
4. if they receive a transfusion during their NIH stay

Primary outcomes:
measure: Positive viral DNA or RNA result
timeFrame: 1, 2, and 4 wk post-Txn
measure: Positive viral antibody result
timeFrame: 12, 24 and/or 6mo
Secondary outcomes:
measure: Viral discovery
timeFrame: 1, 2, and 4 wk and 12, 24 and/or 6mo
Other outcomes:
Locations:
city: Washington
country: United States
facility: Childrens National Medical Center
state: District of Columbia
city: Bethesda
country: United States
facility: NIH Heart Center at Suburban Hospital Johns Hopkins Medicine
state: Maryland
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institutes of Health Clinical Center (CC)
name: Valeria De Giorgi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.