Comparison of Heparin Types; Efficacy and Safety
Anticoagulant Effect and Reversal of Hepalean Compared With PPC Heparin in Patients Undergoing Cardiopulmonary Bypass: a Pilot Randomized Trial
1 other identifier
interventional
21
1 country
1
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 coronary-artery-disease
Started Jun 2011
Shorter than P25 for phase_4 coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2011
CompletedFirst Posted
Study publicly available on registry
April 28, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedMay 15, 2012
May 1, 2012
3 months
April 26, 2011
May 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
ACT after initial dose of heparin
pre-cardiopulmonary bypass initiation; peri-operatively(in seconds)
Total Heparin Dose used
pre-cardiopulmonary bypass initiation to termination of cardiopulmonary bypass; peri-operatively(in minutes)
Coagulation
post-cardiopulmonary inition, at the 45 minute on pump time point; perioperatively to 24 hours post-operatively
Study Arms (2)
Hepalean Heparin
ACTIVE COMPARATORPPC Heparin
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- will be undergoing cardiopulmonary bypass for coronary artery disease
- has provided written informed consent
You may not qualify if:
- Allergy or intolerance to Heparin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hamilton Health Sciences: Hamilton General Hospital
Hamilton, Ontario, L8L 2X2, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin H Teoh, MD
Hamilton Health Sciences: Hamilton General Site
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2011
First Posted
April 28, 2011
Study Start
June 1, 2011
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
May 15, 2012
Record last verified: 2012-05