Clinical trial NCT00901160: Thromboelastography (TEG®) and Platelet Function in Patients on Anti-platelet Agents
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Blood Clotting
Keywords: thromboelastography
post-operative complications
anti-platelet agents
prospective
pilot
patients taking anti-platelet agents
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
name: Hamilton Health Sciences Corporation
First posted: 2009-05-13
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are having non-ambulatory, non-cardiac, elective surgery

Brief 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?

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.

Eligibility criteria: Inclusion Criteria:

* patients on aspirin and/or clopidogrel for at least 10 days, having non-ambulatory, non-cardiac, elective surgery

Exclusion Criteria:

* 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

Primary outcomes:
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.
timeFrame: 1 month
Secondary outcomes:
measure: Is hypercoagulability based on TEG®(MA) and PMA™ associated with increased risk of the following events post-op: MI, stroke, PE, DVT, death?
timeFrame: 1 month
measure: Is hypo-coagulation status associated with lower levels of nadir and discharge hemoglobin/hematocrit and increased transfusion?
timeFrame: 1 month
measure: Is coagulation status associated with hospital length of stay?
timeFrame: 1 month
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Summer Syed, M.D.
role: PRINCIPAL_INVESTIGATOR
References: