Association Between Perioperative Platelet Function and Major Adverse Perioperative Events

Completed

• Conditions: Surgery
• Interventions: Procedure: Blood drawn

• Registration Number: NCT00901030
• Lead Sponsor: Hamilton Health Sciences Corporation

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-05-12
• Study First Submitted QC: 2009-05-12
• Study First Posted: 2009-05-13
• Primary Completion: 2014-10
• Status Verified: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-21
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with PCI on blood thinners	Blood drawn	Patients have a coronary stent and are taking anti-clotting (anti-platelet) drug and are having non-cardiac surgery.

Primary Outcome Measures

Name	Time	Method
Relationship between platelet function and MACE during the perioperative period	1 month

Secondary Outcome Measures

Name	Time	Method
Association of MACE with perioperative platelet function as measured by TEG and PMA	1 month

Trial Locations

Locations (3)

Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada

University Health Network; 🇨🇦 Toronto, Ontario, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada