Association Between Perioperative Platelet Function and M... | NCT00901030

Studies
Association Between Perioperative Platelet Function and Major Adverse Perioperative Events

NCT00901030

Sponsor

McMaster University

Status

Completed

Last Update Posted

Jun 11, 2026Actual

Enrollment

250Actual

Phase

Not provided

Conditions

Surgery

Interventions

Blood drawn

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Oct 2014Actual

Completion Date

Sep 2015Actual

First Submitted Date

May 12, 2009

First Submission Date that Met QC Criteria

May 12, 2009

First Posted Date

May 13, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2026

Last Update Posted Date

Jun 11, 2026Actual

Name	Class
St. Joseph's Healthcare Hamilton	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood drawn	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Relationship between platelet function and MACE during the perioperative period		1 month

Secondary Outcomes

Measure	Description	Time Frame
Association of MACE with perioperative platelet function as measured by TEG and PMA		1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who have PCI have to stay on antiplatelet agents to prevent clotting of their stents. These patients often require NCS at some stage after their PCI.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Summer Syed, M.D.	Hamilton Health Sciences Corporation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hamilton Health Sciences		Hamilton	Ontario	L8L 2X2	Canada
London Health Sciences Centre