Trial | NCT00587444  Report issue

Official Title

Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    heparin ...

  • Study Participants

    270
Study has been completed and is in the data analysis and manuscript writing phase of the project.
Study Started
Jun 30
2001
Primary Completion
Oct 31
2007
Study Completion
Oct 31
2007
Last Update
Oct 15
2009
Estimate

Drug HH or high heparin

initial dose of 450u/kg for CPB ACT performed additional bolus given if result is <600 seconds anytime during CPB

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

Drug 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%

1 Other

control standard dose heparin dose

2 Active Comparator

high dose heparin dose

3 Active Comparator

hepcon guided therapy

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.
No Results Posted