Comparing Point of Care Clotting Tests in the OR Versus Standard Laboratory Clotting Tests

February 28, 2011 updated by: Hamilton Health Sciences Corporation

Comparison Between Point of Care INR and aPTT Hemochron Jr Whole Blood Measurement With Standard Laboratory in Patients Having Elective First Time on Pump Coronary Artery Bypass Grafting (CABG)

The purpose of this study is determine the agreement of point of care (POC) clotting tests (INR and aPTT) by the POC device by Hemochron Jr versus standard laboratory clotting tests (INR and aPTT) in patients undergoing elective cardiac surgery.

Study Overview

Status

Completed

Conditions

Detailed Description

The study is a correlation between POC Hemochron Jr INR and aPTT with the standard.

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patient undergoing elective on pump CABG

Description

Inclusion Criteria:

  • did not receive anticoagulants or clopidogrel within 5 days preoperatively

Exclusion Criteria:

  • history of coagulopathy
  • heparin resistance
  • receiving heparin or warfarin
  • hepatic or renal dysfunction
  • pregnancy
  • urgent or emergency cases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
POC INR and APTT Hemochron
Adult patients undergoing elective on pump coronary artery bypass grafting surgery who have not received anticoagulants or clopidogrel within 5 days preoperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation between pre cardiopulmonary bypass (CPB) and post CPB POC INR and PTT with standard laboratory INR and PTT
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Investigators

  • Principal Investigator: Summer Syed, MD, Hamilton Health Sciences Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

May 4, 2009

First Submitted That Met QC Criteria

May 4, 2009

First Posted (Estimate)

May 5, 2009

Study Record Updates

Last Update Posted (Estimate)

March 2, 2011

Last Update Submitted That Met QC Criteria

February 28, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 07-467

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Bypass Grafting

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe