A Phase III Randomized, Controlled, Superiority Study Evaluating EVARREST® Fibrin Sealant Patch Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Hepatic Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 17
- 主要终点
- Hemostasis at the Target Bleeding Site (TBS) at 4-minutes Following Randomization
研究概览
简要总结
To evaluate the safety and hemostatic effectiveness of EVARREST® Fibrin Sealant Patch (EVARREST) 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 or legally authorized representatives must be willing to participate in the study, and provide written informed consent. (Note: This criteria does allow for hospital translators to be used where approved by Ethics Committees/Institutional Review Boards)
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 EVARREST® 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 medical device or investigational drug trial within 30 days of surgery or are expected to participate in another medical device or investigational drug trial during the course of the study;
- •Female subjects who are pregnant or nursing.
研究组 & 干预措施
Standard of Care (SoC)
SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
干预措施: Standard of Care (SoC) (Other)
EVARREST® Fibrin Sealant Patch
EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
干预措施: EVARREST® Fibrin Sealant Patch (Biological)
结局指标
主要结局
Hemostasis at the Target Bleeding Site (TBS) at 4-minutes Following Randomization
时间窗: Intraoperative, 4 minutes following randomization
Proportion of subjects achieving hemostasis at the TBS at 4-minutes following randomization and with no re-bleeding requiring treatment at the TBS any time prior to initiation of wound closure. Hemostasis is defined as no detectable bleeding at the TBS.
次要结局
- Hemostasis at the Target Bleeding Site (TBS) at 10-minutes Following Randomization(Intraoperative, 10 minutes following randomization)
- Incidence of Re-bleeding Events From the TBS During the Study Follow-up(Up to 60-days following surgery)
- Incidence of Adverse Events (AEs)(Up to 60-days following surgery)
- Incidence of Adverse Events That Were Potentially Related to Thrombotic Events(Up to 60-days following surgery)
- Absolute Time to Hemostasis(Intraoperative, an average of 4.2 minutes following randomization)