Risk of Developing Antibodies to Heparin-PF4 After Heart Surgery

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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 antibodies to the drug. This immune response can lead to the formation of blood clots, setting the stage for a potential heart attack or stroke. The purpose of this study is to evaluate how often an immune response to heparin leads to the formation of blood clots in individuals who have had heart surgery.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Treatments: Antibodies; Calcium heparin; Heparin

Criteria

Inclusion Criteria:

• Scheduled for cardiac bypass surgery at Duke University Hospital

Exclusion Criteria:

• 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