NCT00848796

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 20, 2009

Completed
Last Updated

February 20, 2009

Status Verified

February 1, 2009

Enrollment Period

1.2 years

First QC Date

February 19, 2009

Last Update Submit

February 19, 2009

Conditions

Coronary Artery Bypass Grafting

Keywords

Heparin LeoHepaleanCPB Cardiopuilmonary BypassCABG Coronary Artery Bypass GraftingAnticoagulation efficacy

Outcome Measures

Primary Outcomes (1)

  • Chest tube drainage

    24 to 48 hrs

Secondary Outcomes (3)

  • Amount of heparin used

    1 to 7 hrs

  • Amount of Protamine used

    1 to 7 hrs

  • Measured slope with heparin/ACT titration

    1 to 7 hrs

Study Arms (1)

Heparin

OTHER

Compare two market brands of Heparin

Drug: Heparin Leo and Hepalean

Interventions

Heparin Leo and HepaleanDRUG

Dosage based on Heparin does response curve obtained from the Medtronic HMS plus

Also known as: Heparin Leo, Hepalean
Heparin

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southlake Regional Health Centre

Newmarket, Ontario, L3Y 2P9, Canada

Location

Related Publications (1)

  • Dyck L, Friesen RM. Do different heparin brands influence activated clotting times? J Extra Corpor Technol. 1998 Jun;30(2):73-6.

    PMID: 10182116RESULT

Study Officials

  • Charles M Peniston, MD,FRCP

    Department of Cardiac surgery-S.R.H.C

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 19, 2009

First Posted

February 20, 2009

Study Start

September 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

February 20, 2009

Record last verified: 2009-02

Locations

CA(1)