SurgeryNCT00901030
Association Between Perioperative Platelet Function and Major Adverse Perioperative Events
An observational study of Surgery, run by McMaster University at 3 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Surgery
- What is being tested?
- Blood drawn
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 3 sitesCanada
- Study dates
- Mar 2009to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- clotting abnormalities
- drugs affecting platelet function other than aspirin or clopidogrel
- moderate renal impairment
- liver dysfunction with co-existing thrombocytopenia
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2
London Health Sciences Centre
London, Ontario, N6A 5A5
University Health Network
Toronto, Ontario, M5G 2C4
About this study
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
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).
Read the 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.
- Conditions
- Surgery
- Being tested
- Blood drawn
- Keywords
- platelet function, perioperative complications, thromboelastography, coronary stents, non-cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawnProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Blood drawn |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between platelet function and MACE during the perioperative period
Measured: 1 month
Secondary outcomes (1)
Association of MACE with perioperative platelet function as measured by TEG and PMA
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startMar 2009
- Primary completionOct 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Responsible party
- Sponsor
- Investigators
- Summer Syed, M.D., Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901030
- Sponsor's protocol ID
- 09-066
- Status last verified
- Sep 2015
- First submitted
- 12 May 2009
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00901030
- Acronym / sponsor ID
- 09-066
- Conditions
- Surgery
- Keywords
- platelet function, perioperative complications, thromboelastography, coronary stents, non-cardiac surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Study start
- Mar 2009
- Primary completion
- Oct 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 13 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with PCI on blood thinners | – | Procedure: Blood drawnPatients have a coronary stent and are taking anti-clotting (anti-platelet) drug and are having non-cardiac surgery. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- clotting abnormalities
- drugs affecting platelet function other than aspirin or clopidogrel
- moderate renal impairment
- liver dysfunction with co-existing thrombocytopenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawnBlood 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. | Procedure or surgery | Patients with PCI on blood thinners |
Primary outcome
Relationship between platelet function and MACE during the perioperative period
Time frame: 1 month
1 secondary outcome
Association of MACE with perioperative platelet function as measured by TEG and PMA
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Summer Syed, M.D. principal investigator
Hamilton Health Sciences Corporation
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, run by McMaster University at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between platelet function and MACE during the perioperative period (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.