Thromboelastography (TEG®) and Platelet Function 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?
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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|
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Is hypo-coagulation status associated with lower levels of nadir and discharge hemoglobin/hematocrit and increased transfusion? [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- Is coagulation status associated with hospital length of stay? [ Time Frame: 1 month ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||June 2011|
|Estimated Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
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.
Procedure: blood test
Blood will be taken from patients shortly after surgery in the recovery room in order to perform Thromboelastography® and Platelet Mapping Assay™ tests.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00901160
|Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8L 2X2|
|University Health Network|
|Toronto, Ontario, Canada, M5G 2C4|
|Principal Investigator:||Summer Syed, M.D.||Hamilton Health Sciences Corporation|