Comparison of Heparin Types; Efficacy and Safety

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01343381
• Other study ID #: CANNeCTIN
• Status: Completed
• Phase: Phase 4
• First received: April 26, 2011
• Last updated: May 14, 2012
• Start date: June 2011
• Est. completion date: September 2011

Study information

• Verified date: May 2012
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• will be undergoing cardiopulmonary bypass for coronary artery disease

• has provided written informed consent

Exclusion Criteria:

• Allergy or intolerance to Heparin

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Hepalean Heparin
400 units per kilogram bolus prior to initiation of CPB
• PPC Heparin
400 unit per kilogram bolus prior to initiation of CPB

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences: Hamilton General Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	ACT after initial dose of heparin	A dose of 400 units/kgm will be used	pre-cardiopulmonary bypass initiation; peri-operatively(in seconds)	Yes
Secondary	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)	Yes
Secondary	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	Yes