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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- 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.
研究概览
简要总结
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?
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients on aspirin and/or clopidogrel for at least 10 days, having non-ambulatory, non-cardiac, elective surgery
排除标准
- •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
结局指标
主要结局
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.
时间窗: 1 month
次要结局
- 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)