Hepatitis C in Adults Who Underwent Congenital Heart Surgery Before Screening

November 25, 2013 updated by: William T. Mahle, MD, Emory University

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

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.

Study Overview

Status

Terminated

Conditions

Detailed 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.

Study Type

Observational

Enrollment

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: William T Mahle, MD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1980

Study Completion

July 1, 2006

Study Registration Dates

First Submitted

July 31, 2006

First Submitted That Met QC Criteria

July 31, 2006

First Posted (Estimate)

August 1, 2006

Study Record Updates

Last Update Posted (Estimate)

November 27, 2013

Last Update Submitted That Met QC Criteria

November 25, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0762-2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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