Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass
Phase 3
Completed
- Conditions
- Postoperative Hemorrhage
- Interventions
- Registration Number
- NCT00587444
- Lead Sponsor
- Mayo Clinic
- Brief Summary
Study has been completed and is in the data analysis and manuscript writing phase of the project.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 270
Inclusion Criteria
- Adult male and non-pregnant female patients scheduled for elective cardiac surgery requiring CPB will be eligible for enrollment.
Exclusion Criteria
- Age less than 18 or greater than 90 years; emergency surgery
- Circulatory arrest
- Combined non-cardiac procedures such as carotid endarterectomy
- Congenital heart repair
- Off-CPB coronary artery bypass grafting (CABG)
- Clotting disorder
- Fibrinolytic agents (e.g. streptokinase), severe hepatic disease
- Aprotinin use
- Cooling < 28 degrees C during CPB
- Dialysis dependent renal failure; and
- Platelet receptor GP3a/2b antagonists medication received within 48 hours of surgery. Patients that are not receiving tranexamic acid (TA) intraoperatively will be excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Heparin control standard dose heparin dose 2 HH or high heparin high dose heparin dose 3 heparin concentration HC hepcon guided therapy
- Primary Outcome Measures
Name Time Method measure blood loss within 48 hours
- Secondary Outcome Measures
Name Time Method transfusion requirements 48 hours
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States