Comparison Between Point of Care International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (aPTT) Hemochron Jr Whole Blood Measurement With Standard Laboratory

This study is currently recruiting participants.

Verified by McMaster University, May 2009

First Received: May 4, 2009 No Changes Posted

Sponsored by:	Hamilton Health Sciences
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00892905

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

MedlinePlus related topics: Coronary Artery Bypass Surgery Surgery

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Comparison Between Point of Care INR and aPTT Hemochron Jr Whole Blood Measurement With Standard Laboratory in Patients Having Elective Firt Time on Pump Coronary Artery Bypass Grafting (CABG)

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	20
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	October 2009 (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

Contacts

Contact: Summer Syed, MD	905-521-2100 ext 46698	syeds@mcmaster.ca
Contact: James Hankinson, MD	905-521-2100 ext 44890

Locations

Canada, Ontario
Hamilton General Hospital	Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Summer Syed, MD 905-521-210 ext 46698 syeds@mcmaster.ca
Principal Investigator: Summer Syed, MD
Sub-Investigator: James Hankinson, MD
Sub-Investigator: Julia Anderson, MD
Sub-Investigator: Victor Neira, MD

Sponsors and Collaborators

Hamilton Health Sciences

Investigators

Principal Investigator:

Summer Syed, MD

Hamilton Health Sciences

More Information

No publications provided

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

Keywords provided by McMaster University:

coagulation
INR
aPTT
point of care

laboratory
CABG
surgery

Study placed in the following topic categories:

Thromboplastin

ClinicalTrials.gov processed this record on May 07, 2009