NCT00316212终止2 期
Randomized, Multicenter, Placebo-Controlled, Double-Blind, Parallel Group Study of INS50589 Intravenous Infusion in Subjects Undergoing Coronary Artery Bypass Graft Surgery Involving Cardiopulmonary Bypass
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 160
- 试验地点
- 27
- 主要终点
- Postoperative chest drainage volume
研究概览
简要总结
The purpose of this trial is to identify a dose or doses of INS50589 intravenous infusion that are well-tolerated and which reduce postoperative bleeding and blood product transfusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are scheduled for primary CABG by median sternotomy involving cardiopulmonary bypass
- •Willing to receive allogeneic blood product transfusions during and after surgery
排除标准
- •Have had previous cardiac surgery
- •Have had previous median sternotomy
- •Have tendency for bleeding or family history of bleeding
- •Have an abnormally low platelet count
- •Have received certain anticoagulant or antiplatelet medications within a specified time period prior to the scheduled CABG surgery
结局指标
主要结局
Postoperative chest drainage volume
次要结局
- Requirement for perioperative blood product transfusion
- Incidence of complications after surgery
研究者
研究点 (27)
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