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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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hepalean Heparin | Active Comparator |
| |
| PPC Heparin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hepalean Heparin | Drug | 400 units per kilogram bolus prior to initiation of CPB |
| |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin H Teoh, MD | Hamilton Health Sciences: Hamilton General Site | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton Health Sciences: Hamilton General Hospital | Hamilton | Ontario | L8L 2X2 | Canada |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| PPC Heparin |
| Drug |
400 unit per kilogram bolus prior to initiation of CPB |
|
| 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 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |