Back to resultsComparison of Heparin Types; Efficacy and Safety
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Hepalean Heparin
PPC Heparin
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Heparin, Coronary artery bypass graft surgery, Anti-coagulation efficacy
Eligibility Criteria
Inclusion Criteria:
- will be undergoing cardiopulmonary bypass for coronary artery disease
- has provided written informed consent
Exclusion Criteria:
- Allergy or intolerance to Heparin
Sites / Locations
- Hamilton Health Sciences: Hamilton General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Hepalean Heparin
PPC Heparin
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
ACT after initial dose of heparin
A dose of 400 units/kgm will be used
Total Heparin Dose used
The total dose of heparin needed to maintain an ACT of 480 seconds throught bypass time.
Coagulation
aPTT, TCT, anti-Xa and anti IL IIa activity ant TAT levels after initial heparin dose and after 45 minutes on CPB.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01343381
Brief Title
Comparison of Heparin Types; Efficacy and Safety
Official Title
Anticoagulant Effect and Reversal of Hepalean Compared With PPC Heparin in Patients Undergoing Cardiopulmonary Bypass: a Pilot Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Heparin, Coronary artery bypass graft surgery, Anti-coagulation efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hepalean Heparin
Arm Type
Active Comparator
Arm Title
PPC Heparin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Hepalean Heparin
Intervention Description
400 units per kilogram bolus prior to initiation of CPB
Intervention Type
Drug
Intervention Name(s)
PPC Heparin
Intervention Description
400 unit per kilogram bolus prior to initiation of CPB
Primary Outcome Measure Information:
Title
Feasibility to conduct a larger trial
Description
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
Secondary Outcome Measure Information:
Title
ACT after initial dose of heparin
Description
A dose of 400 units/kgm will be used
Time Frame
pre-cardiopulmonary bypass initiation; peri-operatively(in seconds)
Title
Total Heparin Dose used
Description
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)
Title
Coagulation
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
will be undergoing cardiopulmonary bypass for coronary artery disease
has provided written informed consent
Exclusion Criteria:
Allergy or intolerance to Heparin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin H Teoh, MD
Organizational Affiliation
Hamilton Health Sciences: Hamilton General Site
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Health Sciences: Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Comparison of Heparin Types; Efficacy and Safety
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