Study of Transfusion-Transmitted Infections

NCT00023023 | Completed

• 2 other identifiers: 01023101-CC-0231
• Study Type: observational
• Target: 1,771
• Locations: 1 country
• Sites: 3

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.

Conditions

Viral Disease; Blood Donation; Transfusion-Transmitted Infections

Keywords

Hepatitis; Blood Bank; Viruses; Blood Donors; Blood Recipients; Natural History

Outcome Measures

Primary Outcomes (2)

• 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

• Positive viral antibody result

  Patients tests positive for any number of viral antibodies which could infer transfusion-transmission.

  12, 24 and/or 6mo

Secondary Outcomes (1)

• Viral discovery

  1, 2, and 4 wk and 12, 24 and/or 6mo

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (3)

Childrens National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

NIH Heart Center at Suburban Hospital Johns Hopkins Medicine

Bethesda, Maryland, 20814, United States

Location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 8637512 BACKGROUND

• 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.

  PMID: 9243769 BACKGROUND

• 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.

  PMID: 11017126 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Virus Diseases; Transfusion Reaction; Hepatitis

Condition Hierarchy (Ancestors)

Infections; Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases; Liver Diseases; Digestive System Diseases

Study Officials

• Valeria De Giorgi, Ph.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2001
• First Posted: August 20, 2001
• Study Start: January 17, 2002
• Last Updated: March 27, 2026

Record last verified: 2025-06-11

Locations

US (3)