NCT00587444

Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Postoperative Hemorrhage

Interventions

Type	Name	Description
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	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 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%

Timeline

• Start date: 2001-06-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2008-01-07
• Last updated: 2009-10-15

Locations

1 site across 1 country: United States