Status:

COMPLETED

Comparative Study of Two Brands of Heparin Already on the Market

Lead Sponsor:

Southlake Regional Health Centre

Conditions:

Coronary Artery Bypass Grafting

Eligibility:

All Genders

18-90 years

Phase:

NA

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...

Detailed Description

The study protocol attempts not to change the normal protocol for cardiac surgery too much. The two different brands of heparin-Heparin Leo (Leo pharma) and Hepalean (Organon) are randomized by the f...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

September 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2007

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT00848796

Start Date

September 1 2006

End Date

December 1 2007

Last Update

February 20 2009

Active Locations (1)

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1

Southlake Regional Health Centre

Newmarket, Ontario, Canada, L3Y 2P9