Protocol Details

A Prospective Study of Transfusion-Transmitted Infections

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	01-CC-0231
Sponsoring Institute	National Institutes of Health Clinical Center (CC)
Recruitment Detail	Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: N/A Max Age: N/A
Referral Letter Required	Yes
Population Exclusion(s)	None
Keywords	Hepatitis; Blood Bank; Viruses; Blood Donors; Blood Recipients; Natural History
Recruitment Keyword(s)	Blood Donors; Blood Recipients; Blood Bank
Condition(s)	Viral Disease; Blood Donation; Transfusion-Transmitted Infections
Investigational Drug(s)	None
Investigational Device(s)	None
Intervention(s)	None
Supporting Site	NIH Clinical Center

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.

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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

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Citations:

The risk of transfusion-transmitted viral infections The Retrovirus Epidemiology Donor Study

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.

Alter HJ, Houghton M. Clinical Medical Research Award. Hepatitis C virus and eliminating post-transfusion hepatitis. Nat Med. 2000 Oct;6(10):1082-6.

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Contacts:

Principal Investigator	Referral Contact	For more information:
Valeria De Giorgi, Ph.D. National Institutes of Health Clinical Center (CC) National Institutes of Health Building 10 Room 1N224 10 Center Drive Bethesda, Maryland 20892 (301) 451-6837 degiorgiv@mail.nih.gov	Sarah Fowler, R.N. National Institutes of Health Clinical Center (CC) National Institutes of Health Building 10 Room 1C711 10 Center Drive Bethesda, Maryland 20892 (301) 435-8081 fowlers@cc.nih.gov	Office of Patient Recruitment National Institutes of Health Clinical Center (CC) Building 61, 10 Cloister Court Bethesda, Maryland 20892 Toll Free: 1-800-411-1222 Local Phone: 301-451-4383 TTY: TTY Users Dial 7-1-1 ccopr@nih.gov

Clinical Trials Number:

NCT00023023

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