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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-06-30

Brief Summary

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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?

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Detailed Description

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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.

Conditions

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Blood Clotting

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

blood test

Intervention Type PROCEDURE

Blood will be taken from patients shortly after surgery in the recovery room in order to perform Thromboelastography® and Platelet Mapping Assay™ tests.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No