NCT00977925已完成3 期
A Phase III Randomized, Controlled, Superiority Study Evaluating the Fibrin Pad Versus Standard of Care Treatment in Controlling Severe Soft Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic Surgery
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 26
- 主要终点
- Proportion of subjects achieving hemostasis at the Target Bleeding Site. Hemostasis is defined as no detectable bleeding at the TBS.
研究概览
简要总结
The objective of this study is to evaluate the safety and hemostatic effectiveness of the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling challenging severe soft tissue bleeding during abdominal, pelvic, retroperitoneal, and (non-cardiac) thoracic surgery.
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
- 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
- •Subjects >= 18 years of age, requiring elective, open, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures;
- •Presence of an appropriate severe bleeding soft tissue Target Bleeding Site (TBS) as identified intra-operatively by the surgeon;
- •Subjects must be willing to participate in the study, and provide written informed consent.
排除标准
- •Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure;
- •Bleeding site is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of the FP to blood flow and pressure during healing and absorption of the product;
- •Subject with TBS within an actively infected field;
- •Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine;
- •Subjects with known intolerance to blood products or to one of the components of the study product;
- •Subjects unwilling to receive blood products;
- •Subjects with known immunodeficiency diseases (including known HIV);
- •Subjects who are known, current alcohol and / or drug abusers;
- •Subjects who have participated in another investigational drug or device research study within 30 days of enrollment;
- •Female subjects who are pregnant or nursing.
结局指标
主要结局
Proportion of subjects achieving hemostasis at the Target Bleeding Site. Hemostasis is defined as no detectable bleeding at the TBS.
时间窗: Intra-operative
次要结局
- Proportion of subjects achieving hemostatic success at 10 minutes following randomization(Intra-operative)
- Absolute time to hemostasis(Intra-operative)
- Proportion of subjects requiring re-treatment at the TBS prior to wound closure(Intra-operative)
- Incidence of treatment failures(Intra-operative)
- Incidence of adverse events that are potentially related to bleeding at the TBS(Intra-operative through 60 days)
- Incidence of adverse events that are potentially related to thrombotic events;(Intra-operative through 60 days)
- Incidence of adverse events(Intra-operative through 60 days)
研究者
研究点 (26)
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