NCT01166243已完成3 期
A Phase III Randomized, Controlled, Superiority Study Evaluating the Fibrin Pad Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Elective Hepatic Surgery
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 17
- 主要终点
- Proportion of subjects achieving hemostasis at the Target Bleeding Site (TBS).
研究概览
简要总结
The objective of this study is to evaluate the safety and and hemostatic effectiveness of the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic 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
- None
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 or urgent, open hepatic surgery
- •Presence of an appropriate bleeding hepatic parenchymal 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
- •TBS 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
- •TBS with major arterial bleeding requiring suture or mechanical ligation
- •Subjects admitted for trauma surgery
- •Subject is a transplant patient for fulminant hepatic failure
- •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 or is unwilling to receive blood products
- •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 surgery
- •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 (TBS).
时间窗: Intra-operative
次要结局
- Proportion of subjects achieving hemostasis success at 10-minutes following randomization.(Intra-operative)
- Absolute time to hemostasis(Intraoperative)
- Subjects requiring re-treatment(Intraoperative)
- Incidence of adverse events potentially related to re-bleeding at TBS(Intraoperative through 60 days)
- Incidence of adverse events potentially related to thrombotic events(Intraoperative through 60 days)
- Incidence of adverse events(Intraoperative through 60 days)
研究者
研究点 (17)
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