Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass
Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Hemorrhage
Intervention: Heparin (Drug); HH or high heparin (Drug); heparin concentration HC (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s): William Oliver, MD, Principal Investigator, Affiliation: Mayo Clinic
Summary
Study has been completed and is in the data analysis and manuscript writing phase of the
project.
Clinical Details
Official title: Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: measure blood loss
Secondary outcome: transfusion requirements
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Mayo Clinic, Rochester, Minnesota 55901, United States
Additional Information
Starting date: June 2001
Last updated: October 14, 2009
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