- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01343381
Comparison of Heparin Types; Efficacy and Safety
May 14, 2012 updated by: McMaster University
Anticoagulant Effect and Reversal of Hepalean Compared With PPC Heparin in Patients Undergoing Cardiopulmonary Bypass: a Pilot Randomized Trial
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8L 2X2
- Hamilton Health Sciences: Hamilton General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- will be undergoing cardiopulmonary bypass for coronary artery disease
- has provided written informed consent
Exclusion Criteria:
- Allergy or intolerance to Heparin
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Hepalean Heparin
|
400 units per kilogram bolus prior to initiation of CPB
|
Active Comparator: PPC Heparin
|
400 unit per kilogram bolus prior to initiation of CPB
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility to conduct a larger trial
Time Frame: 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
|
pre-cardiopulmonary bypass initiation; peri-operative period (in minutes) to 24 hours post-operatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ACT after initial dose of heparin
Time Frame: pre-cardiopulmonary bypass initiation; peri-operatively(in seconds)
|
A dose of 400 units/kgm will be used
|
pre-cardiopulmonary bypass initiation; peri-operatively(in seconds)
|
Total Heparin Dose used
Time Frame: 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.
|
pre-cardiopulmonary bypass initiation to termination of cardiopulmonary bypass; peri-operatively(in minutes)
|
Coagulation
Time Frame: 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.
|
post-cardiopulmonary inition, at the 45 minute on pump time point; perioperatively to 24 hours post-operatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kevin H Teoh, MD, Hamilton Health Sciences: Hamilton General Site
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
April 26, 2011
First Submitted That Met QC Criteria
April 27, 2011
First Posted (Estimate)
April 28, 2011
Study Record Updates
Last Update Posted (Estimate)
May 15, 2012
Last Update Submitted That Met QC Criteria
May 14, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CANNeCTIN
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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