Evaluation of Heparin Rebound in Cardiac Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Lawson Health Research Institute
Sponsor:
Collaborator:
Academic Medical Organization of Southwestern Ontario
Information provided by (Responsible Party):
Ravi Taneja, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01675817
First received: August 28, 2012
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients undergoing elective cardiac surgery

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01675817

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

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

No publications provided

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
Study First Received: August 28, 2012
Last Updated: September 27, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
heparin rebound
protamine
cardiopulmonary bypass
cardiac surgery
anti-Xa
anti-IIa

Additional relevant MeSH terms:
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 August 27, 2014