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

Tracking Information

First Received Date ^ICMJE

May 4, 2009

Last Updated Date

February 28, 2011

Start Date ^ICMJE

January 2008

Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00892905 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

Brief Summary

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.

Detailed Description

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

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Adult patient undergoing elective on pump CABG

Condition ^ICMJE

Coronary Artery Bypass Grafting

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

January 2011

Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00892905

Other Study ID Numbers ^ICMJE

07-467

Has Data Monitoring Committee

Responsible Party

Dr. Summer Syed, MD, Hamilton Health Sciences

Study Sponsor ^ICMJE

Hamilton Health Sciences Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Summer Syed, MD

Hamilton Health Sciences Corporation

Information Provided By

McMaster University

Verification Date

January 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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