Clinical trial NCT00901030: Association Between Perioperative Platelet Function and Major Adverse Perioperative Events
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Keywords: platelet function
perioperative complications
thromboelastography
coronary stents
non-cardiac surgery
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
name: London Health Sciences Centre
name: McMaster University
First posted: 2009-05-13
Enrollment: 250
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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

Primary outcomes:
measure: Relationship between platelet function and MACE during the perioperative period
timeFrame: 1 month
Secondary outcomes:
measure: Association of MACE with perioperative platelet function as measured by TEG and PMA
timeFrame: 1 month
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Summer Syed, M.D.
role: PRINCIPAL_INVESTIGATOR
References: