Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass

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

Official Title
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Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass

Conditions
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Postoperative Hemorrhage

Intervention / Treatment
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* Drug: Heparin
* Drug: HH or high heparin
* Drug: heparin concentration HC


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>control standard dose heparin dose | Drug: Heparin<br>* 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<br>|
| Active Comparator: 2<br>high dose heparin dose | Drug: HH or high heparin<br>* initial dose of 450u/kg for CPB ACT performed additional bolus given if result is <600 seconds anytime during CPB<br>|
| Active Comparator: 3<br>hepcon guided therapy | Drug: heparin concentration HC<br>* 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%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure blood loss |  | within 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transfusion requirements |  | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heparin management