Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2007-10-31

Brief Summary

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

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Detailed Description

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Conditions

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Postoperative Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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1

control standard dose heparin dose

Group Type OTHER

Heparin

Intervention Type DRUG

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

2

high dose heparin dose

Group Type ACTIVE_COMPARATOR

HH or high heparin

Intervention Type DRUG

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

3

hepcon guided therapy

Group Type ACTIVE_COMPARATOR

heparin concentration HC

Intervention Type DRUG

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%

Interventions

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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

Intervention Type 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

Intervention Type 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%

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No