Comparison of Heparin Types; Efficacy and Safety

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: PPC Heparin; Drug: Hepalean Heparin

• Registration Number: NCT01343381
• Lead Sponsor: McMaster University

Brief Summary

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?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-26
• Study First Submitted QC: 2011-04-27
• Study First Posted: 2011-04-28
• Study Start: 2011-06
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-14
• Last Update Posted: 2012-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• will be undergoing cardiopulmonary bypass for coronary artery disease
• has provided written informed consent

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Exclusion Criteria

• Allergy or intolerance to Heparin

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PPC Heparin	PPC Heparin	-
Hepalean Heparin	Hepalean Heparin	-

Primary Outcome Measures

Name	Time	Method
Feasibility to conduct a larger trial	pre-cardiopulmonary bypass initiation; peri-operative period (in minutes) to 24 hours post-operatively	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hamilton Health Sciences: Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada