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

McMaster University

Status: Terminated

Conditions: Blood Clotting

Treatments: Procedure: blood test

Study type: Observational

Funder types: Other

Identifiers

NCT00901160

07-468

Details and patient eligibility

About

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?

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Surgical patients

Description:

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.

Treatment:

Procedure: blood test