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
  Purpose

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).


Condition Intervention
Surgery
Procedure: Blood drawn

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Relationship between platelet function and MACE during the perioperative period [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Association of MACE with perioperative platelet function as measured by TEG and PMA [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: March 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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.

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

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00901030

Locations
Canada, Ontario
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 2X2
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
Hamilton Health Sciences Corporation
University Health Network, Toronto
London Health Sciences Centre
McMaster University
Investigators
Principal Investigator: Summer Syed, M.D. Hamilton Health Sciences Corporation
  More Information

No publications provided

Responsible Party: McMaster University ( Hamilton Health Sciences Corporation )
ClinicalTrials.gov Identifier: NCT00901030     History of Changes
Other Study ID Numbers: 09-066
Study First Received: May 12, 2009
Last Updated: February 21, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
platelet function
perioperative complications
thromboelastography
coronary stents
non-cardiac surgery

ClinicalTrials.gov processed this record on August 28, 2014