A Single-blinded, Randomized, Controlled, Comparative Phase III Study Evaluating the Safety and Effectiveness of EVARREST™ Fibrin Sealant Patch as an Adjunct to Hemostasis During Cardiovascular Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 44
- 主要终点
- Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application.
研究概览
简要总结
The objective of this study is to evaluate the safety and effectiveness of the EVARREST™ Fibrin Sealant Patch as an adjunct to hemostasis during cardiovascular 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 an elective or urgent, open aortic surgical procedure utilizing cardiopulmonary bypass. Subjects in Japan between ≥18 and <20 years of age will require consent by the subject's legal representative
- •Subjects must be willing to participate in the study and provide written informed consent.
- •Presence of an appropriate Target Bleeding Site (TBS) along the anastomotic suture line, involving a synthetic aortic graft, as identified intra-operatively by the investigator;
排除标准
- •Subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products;
- •Exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or anticipated in the 60 day follow up period after surgery.
- •Female subjects who are pregnant or nursing.
- •TBS is from a large defects in visible arteries or veins where the injured vascular wall requires repair and maintenance of vessel patency or where there would be persistent exposure of EVARREST™ Fibrin Sealant Patch to blood flow and/or pressure during absorption of the product;
- •TBS with major arterial bleeding requiring suture or mechanical ligation;
- •TBS involves an expanded polytetrafluoroethylene (ePTFE) graft
- •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 any intra-operative findings identified by the investigator that may preclude conduct of the study procedure;
研究组 & 干预措施
Topical hemostat
Equine collagen with Human Fibrinogen and Human Thrombin
干预措施: Topical hemostat (Biological)
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
Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application.
时间窗: Intraoperative, 3 minutes following treatment application
Number of subjects achieving hemostasis at the Target Bleeding Site (TBS) at 3 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure
次要结局
- Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application(Intraoperative, 6 minutes following treatment application)
- Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application(Intraoperative, 10 minutes following treatment application)
- Number of Participants With Re-bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment(Intra-operative, prior initiation of final chest wall closure.)