NCT01879475Unknown不适用
Prospective, Randomised, Controlled Investigation Comparing the Safety and Performance of 032-11 Surgical Haemostat With FLOSEAL® Haemostatic Matrix in Cardiac Surgery and Thoracic Aortic Surgery.
适应症
试验速览
- 阶段
- 不适用
- 发起方
- Medtrade
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Haemostasis success
研究概览
简要总结
The effectiveness objective of this study is to evaluate whether 032-11 is non-inferior to Floseal as an adjunct to achieving haemostasis during surgical procedures involving cardiac and aortic thoracic 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
- •The patient must be equal or greater than 18 years old
- •The patient must have elective or non-elective urgent cardiac surgery or thoracic aortic surgery
- •The patient must have no childbearing potential or have a negative serum or urine pregnancy test within 7 days of the planned surgery or in the opinion of the Investigator performs adequate contraception
- •The patient is willing and able to be contacted for the follow-up visit at 6- 8 weeks
- •The patient must provide written informed consent using a form that is reviewed and approved by the IEC
排除标准
- •The patient is currently enrolled in this or another investigational device or drug trial that has not completed the required follow up period.
- •The patient has a known hypersensitivity to materials of bovine origin
- •The patient does not wish to receive materials of bovine or shellfish origin for any reason
结局指标
主要结局
Haemostasis success
时间窗: Intra-operative
Proportion of patients achieving haemostasis success following the first application of compression.
次要结局
未报告次要终点
研究者
研究点 (2)
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