Association Between Perioperative Platelet Function and Major Adverse Perioperative Events

Sponsor

Hamilton Health Sciences Corporation (Other)

Overall Status

Completed

CT.gov ID

NCT00901030

Collaborator

University Health Network, Toronto (Other), London Health Sciences Centre (Other), McMaster University (Other)

250

Enrollment

Locations

Duration (Months)

83.3

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Surgery	Procedure: Blood drawn

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 Design

Study Type:

Observational

Actual Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Association Between Perioperative Platelet Inhibition (Function) and Major Adverse Perioperative Cardiac Events in Post Percutaneous Coronary Intervention Patients Undergoing Non-cardiac Surgery

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.	Procedure: 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.

Arm

Intervention/Treatment

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.

Procedure: 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.

Outcome Measures

Primary Outcome Measures

Relationship between platelet function and MACE during the perioperative period [1 month]

Secondary Outcome Measures

Association of MACE with perioperative platelet function as measured by TEG and PMA [1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hamilton Health Sciences	Hamilton	Ontario	Canada	L8L 2X2
2	London Health Sciences Centre	London	Ontario	Canada	N6A 5A5
3	University Health Network	Toronto	Ontario	Canada	M5G 2C4