Association Between Perioperative Platelet Function and Major Adverse Perioperative Events

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

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2015-09-30

Brief Summary

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This study will examine the degree of blood thinning (platelet function) in patients coming for non-cardiac surgery on antiplatelet agents using platelet function tests called thromboelastography (TEG) and platelet mapping assay (PMA) and major cardiac complications that occur any time after surgery (perioperative).

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Detailed Description

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Patients who have had stents in their coronary arteries (PCI) have to stay on antiplatelet agents to prevent clotting of their stents. These patients often require non-cardiac surgery (NCS) at some stage after their PCI. The rate of major cardiac complications (MACE)in this population is very high and it is unclear why they are at higher risk than the general population. It is possible their antiplatelet is not adequate, or that surgery causes them to be more clot prone. This is a prospective, multicentre observational study.

Conditions

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Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with PCI on blood thinners

Patients have a coronary stent and are taking anti-clotting (anti-platelet) drug and are having non-cardiac surgery.

Blood drawn

Intervention Type PROCEDURE

Blood samples will be taken once in the preoperative clinic and once again at the end of the surgery in the post anesthetic care unit to do the TEG and PMA tests.

Interventions

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Blood drawn

Blood samples will be taken once in the preoperative clinic and once again at the end of the surgery in the post anesthetic care unit to do the TEG and PMA tests.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients between ages 30-85 years old, receiving post-PCI aspirin and/or clopidogrel therapy
* patients undergoing non-ambulatory, NCS
* patients will have received a bare metal coronary stent within the last 12 months or a drug eluting stent at any time prior to their NCS
* the type of surgery has to be such that there are no contra-indictions to remain on an anti-platelet agent
* surgeon must agree to keep the patient on at least one anti-platelet agent during the perioperative period

Exclusion Criteria

* clotting abnormalities
* drugs affecting platelet function other than aspirin or clopidogrel
* moderate renal impairment
* liver dysfunction with co-existing thrombocytopenia

Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No