Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005339
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Brief Title:
Risk of Post Transfusion Hepatitis C Virus Infection
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 ie 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 ie 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
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
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 ie 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 ie 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
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL045333 | NIH | None | httpsreporternihgovquickSearchR01HL045333 |