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Trial record 44 of 172 for:    "Heart Disease" | "Heparin"

Comparison of Heparin Types; Efficacy and Safety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01343381
Recruitment Status : Completed
First Posted : April 28, 2011
Last Update Posted : May 15, 2012
Information provided by (Responsible Party):
McMaster University

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?

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Hepalean Heparin Drug: PPC Heparin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : June 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Allergy or intolerance to Heparin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01343381

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

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Responsible Party: McMaster University Identifier: NCT01343381     History of Changes
Other Study ID Numbers: CANNeCTIN
First Posted: April 28, 2011    Key Record Dates
Last Update Posted: May 15, 2012
Last Verified: May 2012
Keywords provided by McMaster University:
Coronary artery bypass graft surgery
Anti-coagulation efficacy
Additional relevant MeSH terms:
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Heart Diseases
Calcium heparin
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action