Study of Transfusion-Transmitted Infections

Blood Donation Clinical Trial

Official title:

A Prospective Study of Transfusion-Transmitted Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00023023
• Other study ID #: 010231
• Secondary ID: 01-CC-0231
• Status: Completed
• Start date: January 17, 2002

Study information

• Verified date: September 11, 2023
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1771
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

• 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

Related Conditions & MeSH terms

• Blood Donation
• Communicable Diseases
• Infections
• Transfusion Reaction
• Transfusion-Transmitted Infections
• Viral Disease
• Virus Diseases

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland
United States	NIH Heart Center at Suburban Hospital Johns Hopkins Medicine	Bethesda	Maryland
United States	Childrens National Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
National Institutes of Health Clinical Center (CC)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive viral DNA or RNA result	Patients tests positive for any number of viral RNA/DNA which could infer transfusion-transmission.	1, 2, and 4 wk post-Txn
Primary	Positive viral antibody result	Patients tests positive for any number of viral antibodies which could infer transfusion-transmission.	12, 24 and/or 6mo
Secondary	Viral discovery	Pre- and post- transfusion samples can be used for viral discovery programs employing GWAS, full genome sequencing or other methods that may evolve.	1, 2, and 4 wk and 12, 24 and/or 6mo

External Links

•   NIH Clinical Center Detailed Web Page