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Hepatitis C in Adults Who Underwent Congenital Heart Surgery Before Screening

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00359099
Recruitment Status : Terminated
First Posted : August 1, 2006
Last Update Posted : November 27, 2013
Sponsor:
Information provided by (Responsible Party):
William T. Mahle, MD, Emory University

Tracking Information
First Submitted Date July 31, 2006
First Posted Date August 1, 2006
Last Update Posted Date November 27, 2013
Study Start Date January 1980
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Hepatitis C in Adults Who Underwent Congenital Heart Surgery Before Screening
Official Title Proposal for Retrospective Review of the Prevalence of Hepatitis C Infection in Adult Patients Who Underwent Congenital Heart Surgery Before Screening
Brief 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.
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
Study Design Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Congenital Heart Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Enrollment
 (submitted: July¬†31,¬†2006)
1000
Original Enrollment Same as current
Study Completion Date July 2006
Primary Completion Date Not Provided
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00359099
Other Study ID Numbers 0762-2006
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party William T. Mahle, MD, Emory University
Study Sponsor Emory University
Collaborators Not Provided
Investigators
Principal Investigator: William T Mahle, MD Emory University
PRS Account Emory University
Verification Date November 2013