Platelet Function and Neurological Events Following Carotid Thromboendarterectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 386
- 试验地点
- 1
- 主要终点
- TRAP, ADP and ASPI thresholds to predict neurological events
研究概览
简要总结
Several studies have shown an association between platelet function and stroke in patients undergoing carotid thromboendarterectomy (TEA).
The present study will assess the correlation between platelet function evaluated by the impedance aggregometry and neurological events in patients undergoing carotid TEA.
详细描述
Carotid thrombendarterectomy (TEA) is effective in preventing strokes which are a major cause of mortality and morbidity. Nevertheless, almost 10% of patients undergoing TEA develop a transient and/or permanent neurological injury. There is a growing body of evidence that platelet function is associated with perioperative neurological events in this setting, although the vast majority of patients undergoing carotid TEA are already on antiplatelet agents. The aim of the present study will be to assess the correlation between the platelet function evaluated by the impedance aggregometry (Multiplate ® Analyzer, Roche, Basel, Switzerland) and neurological events in patients undergoing carotid TEA.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Carotid Artery Diseases undergoing carotid thrombendarterectomy
- •Signed consent
排除标准
- •Atrial fibrillation
- •New oral anticoagulant
- •Oral Vitamin k inhibitors
- •Platelet count <80000 per microliter
- •Ongoing ischemic stroke
结局指标
主要结局
TRAP, ADP and ASPI thresholds to predict neurological events
时间窗: immediately before the surgery
It will be find the best cut-off for TRAP, ADP and, ASPI in predicting neurological events
Platelet function and neurological events
时间窗: immediately before the surgery
The platelet function will be evaluated by Multiple Electrode Aggregometry (Multiplate). It will be asses the correlation between thrombin receptor activator peptide 6 (TRAP test), adenosine-5'-diphosphate (ADP test) and arachidonic acid (ASPI test) expressed in arbitrary units area under the curve and neurological events in patients undergoing carotid thrombendarterectomy
次要结局
- 6 months and 1 year neurological events(6 months and 1 year)
- Occurrence of any complications(within 1 month of patients' enrolled or before the hospital discharge)
- 6 months and 1 year mortality(6 months and 1 year)
- Occurence of thromboembolic neurological events(within 1 month of patients' enrolled or before the hospital discharge)
研究者
Fabrizio Monaco
Head of Cardiothoracic and Vascular Anesthesia
Scientific Institute San Raffaele