Blood Clotting
Conditions
Keywords
thromboelastography, post-operative complications, anti-platelet agents, prospective, pilot, patients taking anti-platelet agents
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.
Interventions
PROCEDUREblood test
Blood will be taken from patients shortly after surgery in the recovery room in order to perform Thromboelastography® and Platelet Mapping Assay™ tests.
Sponsors
McMaster University
University Health Network, Toronto
Hamilton Health Sciences Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| Is hypercoagulability based on TEG®(MA) and PMA™ associated with increased risk of the following events post-op: MI, stroke, PE, DVT, death? | 1 month |
| Is hypo-coagulation status associated with lower levels of nadir and discharge hemoglobin/hematocrit and increased transfusion? | 1 month |
| Is coagulation status associated with hospital length of stay? | 1 month |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORSummer Syed, M.D.
Hamilton Health Sciences Corporation
Outcome results
None listed