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

This study has been completed.
Sponsor:
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00892905
First received: May 4, 2009
Last updated: February 28, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


Condition
Coronary Artery Bypass Grafting

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Correlation between pre cardiopulmonary bypass (CPB) and post CPB POC INR and PTT with standard laboratory INR and PTT [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patient undergoing elective on pump CABG

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00892905

Locations
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: Summer Syed, MD Hamilton Health Sciences Corporation
  More Information

No publications provided

Responsible Party: Dr. Summer Syed, MD, Hamilton Health Sciences
ClinicalTrials.gov Identifier: NCT00892905     History of Changes
Other Study ID Numbers: 07-467
Study First Received: May 4, 2009
Last Updated: February 28, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
coagulation
INR
aPTT
point of care
 laboratory
CABG
surgery

ClinicalTrials.gov processed this record on May 23, 2013