NL-OMON34280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 - The Fibrin Pad Liver Study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subjects aged 18 years or over, requiring elective or urgent open hepatic surgery
- •2. Presence of an appropriate bleeding parenchymal Target Bleeding Site (TBS) as identified intraoperatively by the surgeon.
- •3. Subjects must be willing to participate in the study, and provide written informed consent.
排除标准
- •1. Subjects with any intraoperative findings identified by the surgeon that may preclude conduct of the study procedure*
- •2. TBS is from large defects in arteries or vein 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*
- •3. TBS with major arterial bleeding requiring suture or mechanical ligation*
- •4. Subjects admitted for trauma surgery*
- •5. Subject is a transplant patient for fulminant hepatic failure*
- •6. Subject with TBS within an actively infected field*
- •7. Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine.
- •8. Subjects with known intolerance to blood products or to one of the components of the study product*
- •9. Subjects who are known, current alcohol and / or drug abusers*
- •10. Subjects who have participated in another investigational drug or device research study within 30 days of surgery*
- •11. Female subjects who are pregnant or nursing.
研究者
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