Association Between Perioperative Platelet Function and Major Adverse Perioperative Events
This study is currently recruiting participants.
Verified February 2012 by McMaster University
Sponsor:
Hamilton Health Sciences Corporation
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: April 23, 2013
Last verified: February 2012
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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 2013 |
| Estimated Primary Completion Date: | October 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00901030
Contacts
| Contact: Summer Syed, M.D. | 905-521-2100 ext 46698 | syeds@mcmaster.ca |
Locations
| Canada, Ontario | |
| Hamilton Health Sciences | Recruiting |
| Hamilton, Ontario, Canada, L8L 2X2 | |
| Contact: Summer Syed, M.D. 905-521-2100 ext 46698 syeds@mcmaster.ca | |
| London Health Sciences Centre | Recruiting |
| London, Ontario, Canada, N6A 5A5 | |
| Contact: Ronit Lavi, M.D. 519-663-2259 lavironit@hotmail.com | |
| Principal Investigator: Ronit Lavi, M.D. | |
| University Health Network | Recruiting |
| Toronto, Ontario, Canada, M5G 2C4 | |
| Contact: Marcin Wasowicz, M.D. 416-340-3567 Marcin.Wasowicz@uhn.on.ca | |
| Principal Investigator: Marcin Wasowicz, M.D. | |
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: | April 23, 2013 |
| 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 May 22, 2013