Evaluation of Heparin Rebound in Cardiac Surgery

Coagulation Delay Clinical Trial

Official title:

Evaluation of Heparin Rebound in Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01675817
• Other study ID #: R-10-190
• Secondary ID: 16949E
• Status: Completed
• Start date: April 2011
• Est. completion date: March 2013

Study information

• Verified date: September 2012
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Coagulation Delay

Locations

Country	Name	City	State
Canada	Dr. Ravi Taneja	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Academic Medical Organization of Southwestern Ontario

Country where clinical trial is conducted

Canada,