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

Terminated

• Conditions: Blood Clotting
• Interventions: Procedure: blood test

• Registration Number: NCT00901160
• Lead Sponsor: McMaster University

Brief Summary

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?

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 Timeline

• Study Start: 2008-01
• Primary Completion: 2009-03
• Study First Submitted: 2009-05-11
• Study First Submitted QC: 2009-05-12
• Study First Posted: 2009-05-13
• Study Completion: 2011-06
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgical patients	blood test	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.

Primary Outcome Measures

Name	Time	Method
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.	1 month

Secondary Outcome Measures

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

Trial Locations

Locations (2)

University Health Network; 🇨🇦 Toronto, Ontario, Canada

Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada