Status:
COMPLETED
Risk of Developing Antibodies to Heparin-PF4 After Heart Surgery
Lead Sponsor:
Duke University
Conditions:
Thrombosis
Eligibility:
All Genders
18+ years
Brief Summary
Heparin is a drug that is widely used to prevent and treat blood clotting. Individuals undergoing cardiopulmonary bypass surgery are administered high doses of heparin, and some of them develop antibo...
Detailed Description
Heparin is a drug that is widely used to prevent and treat blood clotting. However, heparin can also cause serious adverse events. Individuals undergoing cardiopulmonary bypass surgery are administere...
Eligibility Criteria
Inclusion
- Scheduled for cardiac bypass surgery at Duke University Hospital
Exclusion
- Plans to receive warfarin during the post-operative inpatient stay
- Plans to receive a full anticoagulant dose of low-molecular weight heparin during the post-operative inpatient stay
- Plans to receive a full anticoagulant dose of unfractionated heparin during the post-operative inpatient stay
- Use of any drug other than unfractionated heparin for anticoagulation during cardiopulmonary bypass
- Warfarin, heparin, or low-molecular weight heparin administered during a readmission to the hospital for a reason other than one of this study's outcomes does not constitute criteria for exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
1015 Patients enrolled
Trial Details
Trial ID
NCT00237328
Start Date
June 1 2006
End Date
July 1 2012
Last Update
February 25 2013
Active Locations (4)
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1
Mayo Clinic, Rochester
Rochester, Minnesota, United States, 55905
2
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
3
Duke University Medical Center
Durham, North Carolina, United States, 27710
4
University of Wisconsin
Madison, Wisconsin, United States, 53706