Comparison of Heparin Types; Efficacy and Safety

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01343381
First received: April 26, 2011
Last updated: May 14, 2012
Last verified: May 2012
  Purpose

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?


Condition Intervention Phase
Coronary Artery Disease
Drug: Hepalean Heparin
Drug: PPC Heparin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Anticoagulant Effect and Reversal of Hepalean Compared With PPC Heparin in Patients Undergoing Cardiopulmonary Bypass: a Pilot Randomized Trial

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Feasibility to conduct a larger trial [ Time Frame: pre-cardiopulmonary bypass initiation; peri-operative period (in minutes) to 24 hours post-operatively ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: pre-cardiopulmonary bypass initiation; peri-operatively(in seconds) ] [ Designated as safety issue: Yes ]
    A dose of 400 units/kgm will be used

  • Total Heparin Dose used [ Time Frame: pre-cardiopulmonary bypass initiation to termination of cardiopulmonary bypass; peri-operatively(in minutes) ] [ Designated as safety issue: Yes ]
    The total dose of heparin needed to maintain an ACT of 480 seconds throught bypass time.

  • Coagulation [ Time Frame: post-cardiopulmonary inition, at the 45 minute on pump time point; perioperatively to 24 hours post-operatively ] [ Designated as safety issue: Yes ]
    aPTT, TCT, anti-Xa and anti IL IIa activity ant TAT levels after initial heparin dose and after 45 minutes on CPB.


Enrollment: 21
Study Start Date: June 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hepalean Heparin Drug: Hepalean Heparin
400 units per kilogram bolus prior to initiation of CPB
Active Comparator: PPC Heparin Drug: PPC Heparin
400 unit per kilogram bolus prior to initiation of CPB

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Allergy or intolerance to Heparin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01343381

Locations
Canada, Ontario
Hamilton Health Sciences: Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
McMaster University
Investigators
Principal Investigator: Kevin H Teoh, MD Hamilton Health Sciences: Hamilton General Site
  More Information

No publications provided

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01343381     History of Changes
Other Study ID Numbers: CANNeCTIN
Study First Received: April 26, 2011
Last Updated: May 14, 2012
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
Heparin
Coronary artery bypass graft surgery
Anti-coagulation efficacy

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Calcium heparin
Heparin
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 28, 2014