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Evaluation of Heparin Rebound in Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT01675817
Recruitment Status : Unknown
Verified September 2012 by Ravi Taneja, Lawson Health Research Institute.
Recruitment status was:  Recruiting
First Posted : August 30, 2012
Last Update Posted : September 28, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:

Recent work has shown that heparin rebound is common after cardiac surgery.

The exact doze of protamine required to neutralize heparin at the end of CPB is unknown. Besides, the precise doze of protamine to treat heparin rebound is also unknown. It is also unknown if precise titration of protamine perioperatively in cardiac surgery can influence transfusion requirements after cardiac surgery.

Condition or disease
Coagulation Delay

Detailed Description:

This study will assess how much protamine is required to neutralize residual heparin perioperatively in cardiac surgery through measurement of functional assays of heparin (anti-Xa and anti-IIa levels). In the first phase of this study, protamine titration assays will be carried out on normal pooled plasma incubated with heparin in the laboratory.

Once the correct dose of protamine required to neutralize the heparin is established in the laboratory, the second phase will begin. Herein, plasma samples from patients undergoing cardiac surgery (with anticoagulation with two different commercial preparations of heparin) will be evaluated for residual heparin (Anti-Xa and anti-IIa levels). Protamine titration assays wil then be carried out in vitro to assess neutralization of heparin.

Study Design

Study Type : Observational
Estimated Enrollment : 40 participants
Time Perspective: Prospective
Official Title: Evaluation of Heparin Rebound in Cardiac Surgery
Study Start Date : April 2011
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing elective cardiac surgery

Inclusion Criteria:

  • Age >18 years
  • Written consent
  • Scheduled for cardiac surgery under CPB (cardiopulmonary bypass)--(elective or emergency)
  • 10 patients undergoing cardiac surgery where CPB time is anticipated to be short (isolated primary CABG (coronary artery bypass graft);isolated mitral-valve repair or aortic-valve replacement)
  • 10 patients undergoing cardiac surgery where CPB time is anticipated to be longer (CABG + valve surgery combined; reoperations)

Exclusion Criteria:

  • Known coagulopathies
  • Liver dysfunction
  • Patients receiving unfractionated or low molecular weight heparin thrombin inhibitors, warfarin, antiplatelets within the past 7 days
  • Patients expected to undergo hypothermic CPB or circulatory arrest
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01675817

Contact: Ravi Taneja, MD, FRCPC 519-685-8500 ext 17938 ravi.taneja@lhsc.on.ca

Canada, Ontario
Dr. Ravi Taneja Recruiting
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Lawson Health Research Institute
Academic Medical Organization of Southwestern Ontario
Principal Investigator: Ravi Taneja, MD, FRCPC Lawson Health Research Institute
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ravi Taneja, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01675817     History of Changes
Other Study ID Numbers: R-10-190
16949E ( Other Identifier: REB )
First Posted: August 30, 2012    Key Record Dates
Last Update Posted: September 28, 2012
Last Verified: September 2012

Keywords provided by Ravi Taneja, Lawson Health Research Institute:
heparin rebound
cardiopulmonary bypass
cardiac surgery

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