Association Between Perioperative Platelet Function and Major Adverse Perioperative Events

NCT00901030 | Completed

• 1 other identifier: 09-066
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 3

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).

Conditions

Surgery

Keywords

platelet function; perioperative complications; thromboelastography; coronary stents; non-cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Relationship between platelet function and MACE during the perioperative period

  1 month

Secondary Outcomes (1)

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

  1 month

Study Arms (1)

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

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.

Patients with PCI on blood thinners

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• clotting abnormalities
• drugs affecting platelet function other than aspirin or clopidogrel
• moderate renal impairment
• liver dysfunction with co-existing thrombocytopenia

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• University Health Network, Toronto: collaborator
• London Health Sciences Centre: collaborator
• McMaster University: collaborator

Study Sites (3)

Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Study Officials

• Summer Syed, M.D.

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2009
• First Posted: May 13, 2009
• Study Start: March 1, 2009
• Primary Completion: October 1, 2014
• Study Completion: September 1, 2015
• Last Updated: September 23, 2015

Record last verified: 2015-09

Locations

CA (3)