Association Between Perioperative Platelet Function and Major Adverse Perioperative Events

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University Health Network, Toronto
London Health Sciences Centre
McMaster University
Information provided by (Responsible Party):
McMaster University ( Hamilton Health Sciences Corporation )
ClinicalTrials.gov Identifier:
NCT00901030
First received: May 12, 2009
Last updated: February 21, 2014
Last verified: February 2014

May 12, 2009
February 21, 2014
March 2009
October 2014   (final data collection date for primary outcome measure)
Relationship between platelet function and MACE during the perioperative period [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00901030 on ClinicalTrials.gov Archive Site
Association of MACE with perioperative platelet function as measured by TEG and PMA [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Association Between Perioperative Platelet Function and Major Adverse Perioperative Events
The Association Between Perioperative Platelet Inhibition (Function) and Major Adverse Perioperative Cardiac Events in Post Percutaneous Coronary Intervention Patients Undergoing Non-cardiac Surgery

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).

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

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.
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.
Intervention: Procedure: Blood drawn
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
250
December 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
30 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00901030
09-066
No
McMaster University ( Hamilton Health Sciences Corporation )
Hamilton Health Sciences Corporation
  • University Health Network, Toronto
  • London Health Sciences Centre
  • McMaster University
Principal Investigator: Summer Syed, M.D. Hamilton Health Sciences Corporation
McMaster University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP