Comparison of Heparin Types; Efficacy and Safety

Study Overview
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Brief Summary
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Heparin, a blood thinner, is used routinely in Open-heart surgery. Do different brands of this drug have differing clinical effects despite both having exactly the same regulation and marketing specifications?

Official Title
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Anticoagulant Effect and Reversal of Hepalean Compared With PPC Heparin in Patients Undergoing Cardiopulmonary Bypass: a Pilot Randomized Trial

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Hepalean Heparin
* Drug: PPC Heparin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: will be undergoing cardiopulmonary bypass for coronary artery disease has provided written informed consent Exclusion Criteria: Allergy or intolerance to Heparin

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: Hepalean Heparin<br> | Drug: Hepalean Heparin<br>* 400 units per kilogram bolus prior to initiation of CPB<br>|
| Active Comparator: PPC Heparin<br> | Drug: PPC Heparin<br>* 400 unit per kilogram bolus prior to initiation of CPB<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility to conduct a larger trial | Will the pilot show that the pilot's design is feasible with respect to timely patient enrolment, blinding of treatment allocation, study drug dosage requirements and the collection and measurement of study outcomes; ACT of > 450 seconds after initial pre-CPB heparin bolus, dosage of additional heparin (if any) to maintain an ACT of greater than 450 seconds, differences (if any) in coagulation profiles, differences if any in chest tube drainage, differences (if any) in post-operative transfusion requiements | pre-cardiopulmonary bypass initiation; peri-operative period (in minutes) to 24 hours post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACT after initial dose of heparin | A dose of 400 units/kgm will be used | pre-cardiopulmonary bypass initiation; peri-operatively(in seconds) | 
| Total Heparin Dose used | The total dose of heparin needed to maintain an ACT of 480 seconds throught bypass time. | pre-cardiopulmonary bypass initiation to termination of cardiopulmonary bypass; peri-operatively(in minutes) | 
| Coagulation | aPTT, TCT, anti-Xa and anti IL IIa activity ant TAT levels after initial heparin dose and after 45 minutes on CPB. | post-cardiopulmonary inition, at the 45 minute on pump time point; perioperatively to 24 hours post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heparin, Coronary artery bypass graft surgery, Anti-coagulation efficacy