A Randomized, Controlled, Comparative Phase II 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
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 10
- 主要终点
- Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application.
研究概览
简要总结
This is a three-arm, randomized multicenter study evaluating the safety and effectiveness of EVARREST™ Fibrin Sealant Patch in controlling mild to moderate vascular anastomosis suture line bleeding in 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
- 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 an elective or urgent, open aortic surgical procedure utilizing cardiopulmonary bypass;
- •Subjects must be willing to participate in the study and provide written informed consent.
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 30 day follow up period after surgery.
- •Female subjects who are pregnant or nursing.
研究组 & 干预措施
EVARREST™
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™ (Biological)
Topical hemostat
Equine collagen with Human Fibrinogen and Human Thrombin
干预措施: Topical hemostat (Biological)
Standard of Care
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.
干预措施: Standard of Care (Other)
结局指标
主要结局
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 closur
次要结局
- Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application(Intraoperative, 6 minutes following treatment application)
- Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application(Intraoperative, 10 minutes following treatment application)
- Bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment(Intra-operative, prior initiation of final chest wall closure. Safety Issue:)
- Number of Participants With Adverse Events Potentially Related to Thrombotic Events(30 days (+ 14 days) following surgery)