NCT01639833已完成不适用
A Premarket, Prospective, Randomized, Single-Blind Study to Compare the Veriset™ Hemostatic Patch to TachoSil® as an Adjunct to Hemostasis in Subjects Undergoing Cardiovascular Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 12
- 主要终点
- Time to Hemostasis (TTH)
研究概览
简要总结
The objective of this study is to assess the safety and effectiveness of Veriset™ Hemostatic Patch in cardiovascular procedures by comparing Veriset™ Hemostatic Patch to TachoSil® in subjects undergoing open cardiovascular surgery involving the aorta (e.g., aortic valve replacement (AVR), David procedure, Bentall procedure, abdominal aortic aneurysm repair, etc.), or CABG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Subject has provided informed consent.
- •Subject is ≥18 years of age.
- •Subject is scheduled for surgery involving the aorta (e.g., aortic valve replacement (AVR), David procedure, Bentall procedure, abdominal aortic aneurysm repair, etc.), or coronary artery bypass graft (CABG) where a topical hemostatic agent would be used to control bleeding via an open approach.
- •Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
- •Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where patient is in imminent danger of death.
- •Subject has a history of allergic reactions after application of human fibrinogen, human thrombin and/or collagen of any origin.
- •Subject is pregnant (documented by a positive pregnancy test) or is actively breast-feeding.
- •Subject has an estimated life expectancy of less than 6 months.
- •Subject is unwilling to receive blood products.
- •Subject is scheduled for another planned cardiovascular surgery, and subsequent surgery would jeopardize previous application of study treatment.
- •The subject has participated in another investigational drug or device research study within 30 days of enrollment.
排除标准
- •Subject has an appropriate Target Bleeding Site (TBS) defined as an area of bleeding on the aorta or coronary vessels where hemostasis by conventional methods is ineffective or impractical, and thus necessitates the use of a topical hemostatic agent.
- •TBS Bleeding is Type 2 (Oozing/Mild) or 3 (Moderate).
- •It is possible to hold pressure on Veriset™ Hemostatic Patch or TachoSil® for at least 3 minutes.
- •Incidental finding of any other pre-operative exclusion criteria
- •Subject does not have an appropriate TBS.
- •TBS Bleeding Assessment is Type 1 (No bleeding) or 4 (Severe/Surgical/Life Threatening).
- •Subject has an active local infection at the surgical site.
- •Investigator determines that participation in the study may jeopardize the safety or welfare of the subject.
结局指标
主要结局
Time to Hemostasis (TTH)
时间窗: Day 0
Time to Hemostasis (TTH) at the target bleeding site (TBS) following treatment (Veriset™ Hemostatic Patch or Control).
次要结局
- Hemostasis at All Treated Bleeding Sites Within 3 Minutes(Day 0)
研究者
研究点 (12)
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