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Comparative Study of Two Brands of Heparin Already on the Market

This study has been completed.
Sponsor:
Information provided by:
Southlake Regional Health Centre
ClinicalTrials.gov Identifier:
NCT00848796
First received: February 19, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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 Intervention
Coronary Artery Bypass Grafting
 Drug: Heparin Leo and Hepalean

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Do Different Heparin Brands Influence Bleeding in Coronary Surgery

Resource links provided by NLM:

Drug Information available for: Heparin
U.S. FDA Resources

Further study details as provided by Southlake Regional Health Centre:

Primary Outcome Measures:
  • Chest tube drainage [ Time Frame: 24 to 48 hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Amount of heparin used [ Time Frame: 1 to 7 hrs ] [ Designated as safety issue: No ]
  • Amount of Protamine used [ Time Frame: 1 to 7 hrs ] [ Designated as safety issue: No ]
  • Measured slope with heparin/ACT titration [ Time Frame: 1 to 7 hrs ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: September 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Heparin
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00848796

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

Publications:

Responsible Party: Dr CM Peniston, Southlake Regional Health Centre
ClinicalTrials.gov Identifier: NCT00848796     History of Changes
Other Study ID Numbers: southlake
Study First Received: February 19, 2009
Last Updated: February 19, 2009
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Calcium heparin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
 Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 21, 2013