Platelet Activity in Vascular Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Platelet Activity
研究概览
简要总结
The proposed PIVOTAL study will examine a panel of platelet/coagulation activity markers during the perioperative period. The goal is to develop a clinically useful assessment of platelet/coagulation activity for risk stratification that may ultimately serve as a target for therapeutic intervention. This study will enroll 200 patients with peripheral artery disease undergoing vascular surgery. PIVOTAL is funded by American Heart Association and is scheduled to begin enrollment in July 2013 for approximately two years.
详细描述
To describe platelet activity among PAD subjects undergoing vascular surgery.
To determine whether preoperative platelet activity measurements are independently associated with perioperative cardiovascular events.
To identify demographic, clinical, and surgical factors associated with postoperative platelet activity measurements in patients with established PAD.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects undergoing non emergent vascular surgery
- •Use of aspirin within 48 hours prior to surgery
- •Age > 21 years of age
- •Able and willing to provide written informed consent for the study
排除标准
- •Use of any anticoagulant (Coumadin, heparin) within 24 hours to surgery
- •Use of any Nonsteroidal Antiinflammatory Drug (NSAID) (such as ibuprofen, naproxen, etc.) within 72 hours
- •Thrombocytopenia (platelet count<100) or Thrombocytosis (platelet count>500),
- •Anemia (hemoglobin<9),
- •Severe kidney disease (CrCl<30ml/min),
- •Any known hemorrhagic diathesis.
结局指标
主要结局
Platelet Activity
时间窗: two years
The main outcome measures are platelet activity, coagulation markers, platelet mapping and profiling.
次要结局
- Perioperative Events(Two-years)