Comparative Study of Two Brands of Heparin Already on the Market

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: NCT00848796
Recruitment Status : Completed
First Posted : February 20, 2009
Last Update Posted : February 20, 2009
Information provided by:
Southlake Regional Health Centre

Brief Summary:
Two heparin brands have been in the market in Canada for several years. Heparin Leo from Leo Pharma and Hepalean from Organon. The former is standardized by B.P (British pharmacopeia) while the latter is standardized by U.S.P (United states pharmacopeia). Previous studies have shown Heparin Leo to have roughly a 10% less efficacy then Hepalean. It has also been demonstrated that more protamine is required to reverse Heparin Leo. It is the investigators' intention to study the post-operative effects of the two brands of heparin and whether one of the two causes less bleeding after bypass surgery.

Condition or disease Intervention/treatment Phase
Coronary Artery Bypass Grafting Drug: Heparin Leo and Hepalean Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Do Different Heparin Brands Influence Bleeding in Coronary Surgery
Study Start Date : September 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Compare two market brands of Heparin
Drug: Heparin Leo and Hepalean
Dosage based on Heparin does response curve obtained from the Medtronic HMS plus
Other Names:
  • Heparin Leo
  • Hepalean

Primary Outcome Measures :
  1. Chest tube drainage [ Time Frame: 24 to 48 hrs ]

Secondary Outcome Measures :
  1. Amount of heparin used [ Time Frame: 1 to 7 hrs ]
  2. Amount of Protamine used [ Time Frame: 1 to 7 hrs ]
  3. Measured slope with heparin/ACT titration [ Time Frame: 1 to 7 hrs ]

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Isolated Coronary Artery Bypass Surgery
  • Normal Hematocrit
  • Normal Creatinine
  • Normal Liver function

Exclusion Criteria:

  • Re-do
  • Combination procedure
  • Valve repair/replacement
  • IABP-pre/Intra/Post-op
  • Cell saver intra-op
  • Anemia (70 g/L)/Bleeding disorder, e.g.,: Jehovah's witness, hemophilia etc.
  • Use of aprotinin
  • Small adult < 50 kg
  • Aortic surgery with/without circ. arrest
  • Emergent patient with heart failure

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): NCT00848796

Canada, Ontario
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y 2P9
Sponsors and Collaborators
Southlake Regional Health Centre
Principal Investigator: Charles M Peniston, MD,FRCP Department of Cardiac surgery-S.R.H.C

Publications of Results:
Responsible Party: Dr CM Peniston, Southlake Regional Health Centre Identifier: NCT00848796     History of Changes
Other Study ID Numbers: southlake
First Posted: February 20, 2009    Key Record Dates
Last Update Posted: February 20, 2009
Last Verified: February 2009

Keywords provided by Southlake Regional Health Centre:
Heparin Leo
CPB Cardiopuilmonary Bypass
CABG Coronary Artery Bypass Grafting
Anticoagulation efficacy

Additional relevant MeSH terms:
Calcium heparin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action