Protocol Details
A Prospective Study of Transfusion-Transmitted Infections
This study is NOT currently recruiting participants.
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.
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
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.
Contacts:
Clinical Trials Number:
NCT00023023