Thromboelastography (TEG®) and Platelet Function in Patients on Anti-platelet Agents

April 7, 2015 updated by: McMaster University

Pilot Study for the Prediction of Post-operative Thrombotic and Bleeding Complications in Non-cardiac Surgery Using Thromboelastography (TEG®) and Platelet Mapping Assay (PMA™) in Patients on Anti-platelet Agents

Can a post-operative analysis using a simple blood test (Thromboelastography(TEG®)) and Platelet Mapping Assay (PMA™) be able to detect the occurence of clotting or bleeding complications in patients on blood thinning (anti-platelet) agents?

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Two hundred patients coming for surgery who are taking anti-platelet medications will be enrolled in this study as a pilot, to determine the feasibility for a larger study. A simple blood test for clotting function will be done after surgery. Patients will be assessed daily during their hospital stay to determine if they have any clotting or bleeding complications. For analysis, groups will be divided into normal and increased or decreased ability to make a blood clot based on the TEG® and PMA™ test done. Complications will be recorded for each group and analyzed to determine if there is any difference between groups.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton Health Sciences
      • Toronto, Ontario, Canada, M5G 2C4
        • University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are having non-ambulatory, non-cardiac, elective surgery

Description

Inclusion Criteria:

  • patients on aspirin and/or clopidogrel for at least 10 days, having non-ambulatory, non-cardiac, elective surgery

Exclusion Criteria:

  • anemia (Hb < 100) or thrombocytopenia (platelet count < 80), having any known clotting abnormalities
  • family history of clotting abnormalities
  • concurrently on NSAIDs, warfarin therapy or other treatments affecting platelet function
  • renal impairment (Cr > 110 mg for females or Cr > 125 mg) or INR > 1.2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgical patients
Blood will be taken from patients who are on anti-platelet medication and are having surgery that requires an overnight stay. This is a pilot study to see if Thromboelastography® and Platelet Mapping Assay™ will be able to predict if a patient is at risk for a bleeding or a clotting problem after surgery.
Procedure: blood test
Blood will be taken from patients shortly after surgery in the recovery room in order to perform Thromboelastography® and Platelet Mapping Assay™ tests.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patients undergoing non-cardiac (non-ambulatory) surgery and are on anti-platelet agents, is hyper or hypocoagulability based on TEG® and PMA™ associated with increased risk of thrombotic and bleeding complications.
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Is hypercoagulability based on TEG®(MA) and PMA™ associated with increased risk of the following events post-op: MI, stroke, PE, DVT, death?
Time Frame: 1 month
1 month
Is hypo-coagulation status associated with lower levels of nadir and discharge hemoglobin/hematocrit and increased transfusion?
Time Frame: 1 month
1 month
Is coagulation status associated with hospital length of stay?
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

University Health Network, Toronto
Hamilton Health Sciences Corporation

Investigators

  • Principal Investigator: Summer Syed, M.D., Hamilton Health Sciences Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

May 11, 2009

First Submitted That Met QC Criteria

May 12, 2009

First Posted (Estimate)

May 13, 2009

Study Record Updates

Last Update Posted (Estimate)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 7, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-468

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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