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?
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
21
400 units per kilogram bolus prior to initiation of CPB
400 unit per kilogram bolus prior to initiation of CPB
Hamilton Health Sciences: Hamilton General Hospital
Hamilton, Ontario, Canada
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
Time frame: pre-cardiopulmonary bypass initiation; peri-operative period (in minutes) to 24 hours post-operatively
ACT after initial dose of heparin
A dose of 400 units/kgm will be used
Time frame: 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.
Time frame: 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.
Time frame: post-cardiopulmonary inition, at the 45 minute on pump time point; perioperatively to 24 hours post-operatively
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