Hepatitis C in Adults Who Underwent Congenital Heart Surgery Before Screening

Congenital Heart Disease Clinical Trial

Official title:

Proposal for Retrospective Review of the Prevalence of Hepatitis C Infection in Adult Patients Who Underwent Congenital Heart Surgery Before Screening

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00359099
• Other study ID #: 0762-2006
• Status: Terminated
• Phase: N/A
• First received: July 31, 2006
• Last updated: November 25, 2013
• Start date: January 1980
• Est. completion date: July 2006

Study information

• Verified date: November 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

This is a retrospective chart review. We hypothesize that patients who have undergone congenital heart surgery, prior to screening of blood products have a significant risk of hepatitis C infection and all such patients would benefit from screening for hepatitis C.

Description:

The Adult Congenital Clinic at Emory Hospital routinely screens all patients who have had congenital heart surgery prior to 1992 for hepatitis C antibodies. It is currently not the practice norm for all congenital heart patients to receive hepatitis screening unless they are at a specialized clinic that has implemented a system. The question of hepatitis C serology is particularly important for this population as many of these patients develop heart failure and may require heart transplantation and immunosuppression.

This is a retrospective analysis examining the prevalence of hepatitis C in the Adult Congenital Clinic at The Emory Clinic. The current practice is to screen all adult congenital heart disease patients for hepatitis C. All Emory clinic charts reviewed will be of patients who had congenital heart surgery. Only information on patients who had surgery prior to 1992 will be used for this study. We will review approximately 1000 charts for this study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1000
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients seen at Emory Adult Congenital Clinic

• patients > 18 years of age

• underwent surgery for congenital heart disease prior to 1992

Exclusion Criteria:

• history of known hepatitis prior to congenital heart surgery

• history of intravenous drug abuse

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States,