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Association Between Perioperative Platelet Function and Major Adverse Perioperative Events

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ClinicalTrials.gov Identifier: NCT00901030
Recruitment Status : Completed
First Posted : May 13, 2009
Last Update Posted : September 23, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment
Surgery Procedure: Blood drawn

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.

Study Design

Study Type : Observational
Actual Enrollment : 250 participants
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
Study Start Date : March 2009
Primary Completion Date : October 2014
Study Completion Date : September 2015
Groups and Cohorts

Group/Cohort Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Relationship between platelet function and MACE during the perioperative period [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Association of MACE with perioperative platelet function as measured by TEG and PMA [ Time Frame: 1 month ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT00901030     History of Changes
Other Study ID Numbers: 09-066
First Posted: May 13, 2009    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015

Keywords provided by McMaster University ( Hamilton Health Sciences Corporation ):
platelet function
perioperative complications
thromboelastography
coronary stents
non-cardiac surgery