Evaluation of Heparin Rebound in Cardiac Surgery

NCT ID: NCT01675817

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2013-03-31

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.

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.

Conditions

Coagulation Delay

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Academic Medical Organization of Southwestern Ontario

OTHER

Sponsor Role: collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ravi Taneja, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Locations

Dr. Ravi Taneja

London, Ontario, Canada

Countries

Canada

References

Taneja R, Berry L, Pappu U, Stitt L, Sayal P, Allen P, Hoogendoorn H, Chan A. Protamine requirements in cardiac surgery: effect of changes in the heparin reference standard. J Cardiothorac Vasc Anesth. 2014 Oct;28(5):1227-32. doi: 10.1053/j.jvca.2014.04.024.

Reference Type: DERIVED

PMID: 25281041 (View on PubMed)

Other Identifiers

16949E

Identifier Type: OTHER

Identifier Source: secondary_id

R-10-190

Identifier Type: -

Identifier Source: org_study_id