NCT01637025已完成不适用
A Prospective, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Traumastem as an Adjunct to Hemostasis for Tissue Bleeding in Open Cardiac, Intra-abdominal (Including Retroperitoneal) and Pelvic Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 24
- 主要终点
- Occurrence of adverse events (AEs)/ adverse device effects (ADEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of Traumastem to help stop bleeding in participants undergoing open cardiac, intra-abdominal (including retroperitoneal) and pelvic surgery as compared to Surgicel® Original (Surgicel; in some countries marketed as Tabotamp®)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Occurrence of adverse events (AEs)/ adverse device effects (ADEs)
时间窗: ≤30 ± 5 days/ end-of-study visit after device application
Occurrence of adverse events (AEs)/ adverse device effects (ADEs) up to 30 ± 5 days/ end-of-study visit after device application.
次要结局
未报告次要终点
研究者
研究点 (24)
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