NCT00359099

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1980

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1980

Completed
26.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 1, 2006

Completed
Last Updated

November 27, 2013

Status Verified

November 1, 2013

First QC Date

July 31, 2006

Last Update Submit

November 25, 2013

Conditions

Congenital Heart Disease

Keywords

Hepatic MedicineSurgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients seen at Emory Adult Congenital Clinic
  • patients \> 18 years of age
  • underwent surgery for congenital heart disease prior to 1992

You may not qualify if:

  • history of known hepatitis prior to congenital heart surgery
  • history of intravenous drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • William T Mahle, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 31, 2006

First Posted

August 1, 2006

Study Start

January 1, 1980

Study Completion

July 1, 2006

Last Updated

November 27, 2013

Record last verified: 2013-11

Locations

US(1)