Evaluation of Heparin Rebound in Cardiac Surgery

Sponsor

Lawson Health Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT01675817

Collaborator

Academic Medical Organization of Southwestern Ontario (Other)

Enrollment

Location

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

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	Intervention/Treatment	Phase
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

Actual Enrollment :

20 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Evaluation of Heparin Rebound in Cardiac Surgery

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

Mar 1, 2013

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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