Blood ClottingNCT00901160
Thromboelastography (TEG®) and Platelet Function in Patients on Anti-platelet Agents
An observational study of Blood Clotting, run by McMaster University at 2 sites in Canada.
Trial summary
Can a post-operative analysis using a simple blood test (Thromboelastography(TEG®)) and Platelet Mapping Assay (PMA™) be able to detect the occurence of clotting or bleeding complications in patients on blood thinning (anti-platelet) agents? Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Blood Clotting
- What is being tested?
- blood test
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2008to Jun 2011
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are having non-ambulatory, non-cardiac, elective surgery
Who may be able to join
- patients on aspirin and/or clopidogrel for at least 10 days, having non-ambulatory, non-cardiac, elective surgery
Who cannot join
- anemia (Hb < 100) or thrombocytopenia (platelet count < 80), having any known clotting abnormalities
- family history of clotting abnormalities
- concurrently on NSAIDs, warfarin therapy or other treatments affecting platelet function
- renal impairment (Cr > 110 mg for females or Cr > 125 mg) or INR > 1.2
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2
University Health Network
Toronto, Ontario, M5G 2C4
About this study
Official title: Pilot Study for the Prediction of Post-operative Thrombotic and Bleeding Complications in Non-cardiac Surgery Using Thromboelastography (TEG®) and Platelet Mapping Assay (PMA™) in Patients on Anti-platelet Agents
Can a post-operative analysis using a simple blood test (Thromboelastography(TEG®)) and Platelet Mapping Assay (PMA™) be able to detect the occurence of clotting or bleeding complications in patients on blood thinning (anti-platelet) agents?
Read the detailed description
Two hundred patients coming for surgery who are taking anti-platelet medications will be enrolled in this study as a pilot, to determine the feasibility for a larger study. A simple blood test for clotting function will be done after surgery. Patients will be assessed daily during their hospital stay to determine if they have any clotting or bleeding complications. For analysis, groups will be divided into normal and increased or decreased ability to make a blood clot based on the TEG® and PMA™ test done. Complications will be recorded for each group and analyzed to determine if there is any difference between groups.
- Conditions
- Blood Clotting
- Being tested
- blood test
- Keywords
- thromboelastography, post-operative complications, anti-platelet agents, prospective, pilot, patients taking anti-platelet agents
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood testProcedure or surgery
Blood will be taken from patients shortly after surgery in the recovery room in order to perform Thromboelastography® and Platelet Mapping Assay™ tests.
| Study group | Role | What they receive |
|---|---|---|
| Surgical patients | Blood will be taken from patients who are on anti-platelet medication and are having surgery that requires an overnight stay. This is a pilot study to see if Thromboelastography® and Platelet Mapping Assay™ will be able to predict if a patient is at risk for a bleeding or a clotting problem after surgery. Receives: Procedure: blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients undergoing non-cardiac (non-ambulatory) surgery and are on anti-platelet agents, is hyper or hypocoagulability based on TEG® and PMA™ associated with increased risk of thrombotic and bleeding complications.
Measured: 1 month
Secondary outcomes (3)
Is hypercoagulability based on TEG®(MA) and PMA™ associated with increased risk of the following events post-op: MI, stroke, PE, DVT, death?
Measured: 1 month
Is hypo-coagulation status associated with lower levels of nadir and discharge hemoglobin/hematocrit and increased transfusion?
Measured: 1 month
Is coagulation status associated with hospital length of stay?
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 startJan 2008
- Primary completionMar 2009
- Study completionJun 2011
Why it stopped: Unable to get funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood ClottingStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto, Hamilton Health Sciences Corporation
- Responsible party
- Sponsor
- Investigators
- Summer Syed, M.D., Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901160
- Sponsor's protocol ID
- 07-468
- Status last verified
- Apr 2025
- First submitted
- 11 May 2009
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for the Prediction of Post-operative Thrombotic and Bleeding Complications in Non-cardiac Surgery Using Thromboelastography (TEG®) and Platelet Mapping Assay (PMA™) in Patients on Anti-platelet Agents
- ClinicalTrials.gov ID
- NCT00901160
- Acronym / sponsor ID
- 07-468
- Conditions
- Blood Clotting
- Keywords
- thromboelastography, post-operative complications, anti-platelet agents, prospective, pilot, patients taking anti-platelet agents
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to get funding
- Enrolment
- 200 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- University Health Network, Toronto, Hamilton Health Sciences Corporation
- Study start
- Jan 2008 (actual)
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jun 2011 (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.
Can a post-operative analysis using a simple blood test (Thromboelastography(TEG®)) and Platelet Mapping Assay (PMA™) be able to detect the occurence of clotting or bleeding complications in patients on blood thinning (anti-platelet) agents?
Detailed description
Two hundred patients coming for surgery who are taking anti-platelet medications will be enrolled in this study as a pilot, to determine the feasibility for a larger study. A simple blood test for clotting function will be done after surgery. Patients will be assessed daily during their hospital stay to determine if they have any clotting or bleeding complications. For analysis, groups will be divided into normal and increased or decreased ability to make a blood clot based on the TEG® and PMA™ test done. Complications will be recorded for each group and analyzed to determine if there is any difference between groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical patients | – | Procedure: blood testBlood will be taken from patients who are on anti-platelet medication and are having surgery that requires an overnight stay. This is a pilot study to see if Thromboelastography® and Platelet Mapping Assay™ will be able to predict if a patient is at risk for a bleeding or a clotting problem after surgery. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are having non-ambulatory, non-cardiac, elective surgery
Key inclusion criteria (1 listed)
- patients on aspirin and/or clopidogrel for at least 10 days, having non-ambulatory, non-cardiac, elective surgery
Key exclusion criteria (4 listed)
- anemia (Hb < 100) or thrombocytopenia (platelet count < 80), having any known clotting abnormalities
- family history of clotting abnormalities
- concurrently on NSAIDs, warfarin therapy or other treatments affecting platelet function
- renal impairment (Cr > 110 mg for females or Cr > 125 mg) or INR > 1.2
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 testBlood will be taken from patients shortly after surgery in the recovery room in order to perform Thromboelastography® and Platelet Mapping Assay™ tests. | Procedure or surgery | Surgical patients |
Primary outcome
Patients undergoing non-cardiac (non-ambulatory) surgery and are on anti-platelet agents, is hyper or hypocoagulability based on TEG® and PMA™ associated with increased risk of thrombotic and bleeding complications.
Time frame: 1 month
3 secondary outcomes
Is hypercoagulability based on TEG®(MA) and PMA™ associated with increased risk of the following events post-op: MI, stroke, PE, DVT, death?
Time frame: 1 month
Is hypo-coagulation status associated with lower levels of nadir and discharge hemoglobin/hematocrit and increased transfusion?
Time frame: 1 month
Is coagulation status associated with hospital length of stay?
Time frame: 1 month
Results and safety
The study was stopped early (reason given: Unable to get funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Clotting, run by McMaster University at 2 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 1 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: stopped early, as of the sponsor's last update on 10 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 2 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 was stopped early (reason given: Unable to get funding). Results are not available in the source record.
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?
Patients undergoing non-cardiac (non-ambulatory) surgery and are on anti-platelet agents, is hyper or hypocoagulability based on TEG® and PMA™ associated with increased risk of thrombotic and bleeding complications. (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 10 Jun 2026.