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Completed

NCT Number: NCT00901030

Association Between Perioperative Platelet Function and Major Adverse Perioperative Events

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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Key information

Conditions

Surgery

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hamilton Health Sciences, Hamilton, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Relationship between platelet function and MACE during the perioperative period

    Time frame: 1 month

Secondary outcomes

  1. Association of MACE with perioperative platelet function as measured by TEG and PMA

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • St. Joseph's Healthcare Hamilton

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2014
Study completion
2015
First posted
May 13, 2009
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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