A Phase 4 interventional study of Hepalean Heparin and PPC Heparin in Coronary Artery Disease, sponsored by McMaster University. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-05-15.
Sponsored by McMaster University · Phase 4, Interventional, and Treatment
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?
5,598 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.
This study's enrollment of 21 is below the median of 123 across 3,435 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Hepalean Heparin
Drug: PPC Heparin
400 units per kilogram bolus prior to initiation of CPB
400 unit per kilogram bolus prior to initiation of CPB
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
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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