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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00892905
Other study ID # 07-467
Secondary ID
Status Completed
Phase N/A
First received May 4, 2009
Last updated February 28, 2011
Start date January 2008
Est. completion date January 2011

Study information

Verified date January 2011
Source McMaster University
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Observational

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date January 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Hamilton General Hospital Hamilton Ontario

Sponsors (1)

Lead Sponsor Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation between pre cardiopulmonary bypass (CPB) and post CPB POC INR and PTT with standard laboratory INR and PTT 2 months No
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