Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass

Postoperative Hemorrhage Clinical Trial

— Heparin Dosing  

Official title:

Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00587444
• Other study ID #: 330-01
• Secondary ID: 3300100CR4023159
• Status: Completed
• Phase: Phase 3
• First received: December 21, 2007
• Last updated: October 14, 2009
• Start date: June 2001
• Est. completion date: October 2007

Study information

• Verified date: October 2009
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Study has been completed and is in the data analysis and manuscript writing phase of the project.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postoperative Hemorrhage

Intervention

Drug:
• Heparin
300u/kg of heparin for CPB ACT performed. If ACT is < 480 seconds a bolus of 5000u heparin will be given. ACT will be repeated and bolus given until ACT is>480 seconds
• HH or high heparin
initial dose of 450u/kg for CPB ACT performed additional bolus given if result is <600 seconds anytime during CPB
• heparin concentration HC
will have anticoagulation during CPB assessed with heparin concentration monitoring and heparin dose response (HDR) to determine the optimal dosage of heparin. This group will evaluate the possible benefit of the HDR to determine heparin dosing and monitoring to achieve maximal suppression of thrombin compared to a fixed dose of heparin as the other two groups. Additional heparin doses will be given to maintain a specific heparin concentration according to the HDR. This is a recognized way of managing heparin dosing and anticoagulation for CPB. All three groups will have heparin neutralized by protamine. Adequacy of heparin neutralization will be based on a difference between the ACT and heparinase-treated ACT values of less than 10%

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measure blood loss		within 48 hours	Yes
Secondary	transfusion requirements		48 hours	Yes