NCT00892905

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 5, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

3 years

First QC Date

May 4, 2009

Last Update Submit

June 8, 2026

Conditions

Coronary Artery Bypass Grafting

Keywords

coagulationINRaPTTpoint of carelaboratoryCABGsurgery

Outcome Measures

Primary Outcomes (1)

  • Correlation between pre cardiopulmonary bypass (CPB) and post CPB POC INR and PTT with standard laboratory INR and PTT

    2 months

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patient undergoing elective on pump CABG

You may qualify if:

  • did not receive anticoagulants or clopidogrel within 5 days preoperatively

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Summer Syed, MD

    Hamilton Health Sciences Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2009

First Posted

May 5, 2009

Study Start

January 1, 2008

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

June 10, 2026

Record last verified: 2026-06

Locations

CA(1)