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Risk of Post Transfusion Hepatitis C Virus Infection
This study has been completed.
Study NCT00005339   Information provided by National Heart, Lung, and Blood Institute (NHLBI)
First Received: May 25, 2000   Last Updated: June 23, 2005   History of Changes

May 25, 2000
June 23, 2005
February 1992
 
 
 
Complete list of historical versions of study NCT00005339 on ClinicalTrials.gov Archive Site
 
 
 
Risk of Post Transfusion Hepatitis C Virus Infection
 

To determine the risk of transfusion-transmitted hepatitis C virus (HCV) in cardiac surgery patients before and after donor screening for anti-HCV and surrogate markers of non-A, non-B hepatitis (NANBH). Also, to characterize donors who were HCV seronegative and who lacked surrogate markers at the time of donation, but whose recipient seroconverted to HCV.

BACKGROUND:

In the early 1990s, posttransfusion NANBH, mainly caused by HCV, was the most common serious complication of transfusions, occurring in 2-5 percent of transfusion recipients. About 50 percent of those infected developed chronic hepatitis, of whom, 10 to 20 percent developed cirrhosis. Hepatocellular carcinoma had been reported to occur in some. This study provided the first evaluation of the effectiveness of donor screening for anti-HCV by the then recently licensed HCV antibody test and surrogate markers of NANBH. It also provided a precise estimate of the risk of transfusion-transmitted HCV. The results allowed examination of risk factors for HCV infected donors who were seronegative at the time of donation.

DESIGN NARRATIVE:

The study was a nonconcurrent prospective, seroepidemiologic study. To estimate the incidence of HCV infection, six-month postoperative serum samples were tested for antibody to HCV. Preoperative samples corresponding to positive postoperative sera were also tested. The donors of a patient who received blood screened for HCV, i.e., a donation since May, 1990, and seroconverted in the six months since transfusion were located and retested for antibodies to HCV. The donors were administered a questionnaire designed to ascertain risk factors for HCV infection. A sample of donors who were HCV positive at the time of donation were given the same questionnaire. Comparison of these three groups of donors (i.e., seropositives, donors tested negative but implicated in seroconversion, seronegatives) allowed an investigation of factors associated with false negative screening results. Analytical methods included standard methods for contingency tables and both conditional and unconditional logistic regression.

 
Observational
Natural History
  • Hepatitis, Viral, Human
  • Blood Transfusion
  • Blood Donors
 
 
Donahue JG, Munoz A, Ness PM, Brown DE Jr, Yawn DH, McAllister HA Jr, Reitz BA, Nelson KE. The declining risk of post-transfusion hepatitis C virus infection. N Engl J Med. 1992 Aug 6;327(6):369-73.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
April 1994
 

No eligibility criteria

Male
 
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00005339
 
4201
National Heart, Lung, and Blood Institute (NHLBI)
 
 
National Heart, Lung, and Blood Institute (NHLBI)
June 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP