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Evaluation of Heparin Rebound in Cardiac Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Lawson Health Research Institute.
Recruitment status was:  Recruiting
Academic Medical Organization of Southwestern Ontario
Information provided by (Responsible Party):
Ravi Taneja, Lawson Health Research Institute Identifier:
First received: August 28, 2012
Last updated: September 27, 2012
Last verified: September 2012

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.

Coagulation Delay

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of Heparin Rebound in Cardiac Surgery

Resource links provided by NLM:

Further study details as provided by Lawson Health Research Institute:

Estimated Enrollment: 40
Study Start Date: April 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
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.


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
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Please refer to this study by its identifier: NCT01675817

Contact: Ravi Taneja, MD, FRCPC 519-685-8500 ext 17938

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 Identifier (NCT Number):
Responsible Party: Ravi Taneja, Principal Investigator, Lawson Health Research Institute Identifier: NCT01675817     History of Changes
Other Study ID Numbers: R-10-190
16949E ( Other Identifier: REB )
Study First Received: August 28, 2012
Last Updated: September 27, 2012

Keywords provided by 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 processed this record on May 25, 2017