NCT02164201已完成不适用
Post Market Surveillance Study Evaluating the Operative Management of Anastomotic Bleeding by Means of an Adjunctive Application of BioFoam Surgical Matrix in Cardiovascular Surgery
CryoLife Europa2 个研究点 分布在 2 个国家目标入组 75 人开始时间: 2014年8月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Achievement of haemostasis
研究概览
简要总结
This is a prospective, multicenter, single-arm study designed to collect clinical data to support the safety and effectiveness of BioFoam used as a surgical adjunct to anastomotic hemostasis following cardiovascular surgery.
The overall objective of this clinical study is to collect clinical data supporting the safety and effectiveness of BioFoam used as a surgical adjunct to anastomotic hemostasis following cardiovascular surgery. This study is intended as a post-market surveillance (follow-up) study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 is undergoing an elective cardiac or cardiovascular procedure;
- •Subject is willing and able to give prior written informed consent for investigation participation; and
- •Subject is > 18 years of age.
- •Intraoperative inclusion criteria include:
- •Subject that requires the use of an adjunctive surgical hemostatic agent to the repair site to control generalized oozing following standard repair procedures (such as sutures and staples).
排除标准
- •• Subject with known hypersensitivity to albumin, bovine products, or glutaraldehyde;
- •Subject with active infection (either systemic or in the repair region);
- •Subject whose pathology or underlying disease state makes them an unacceptable candidate for a clinical investigation in the opinion of the Investigator;
- •Subject diagnosed with a coagulation disorder;
- •Subject with abnormal calcium metabolism (e.g., chronic renal failure, hyperparathyroidism);
- •Subject whose life expectancy is less than that required for the prescribed follow-up duration;
- •Subject who is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding; or
- •Subject who is immunocompromised.
- •Intraoperative exclusion criteria include:
- •Any major intraoperative bleeding incidences (i.e., American College of Surgeons Advanced Trauma Life Support Class II, III, or IV Hemorrhage).
结局指标
主要结局
Achievement of haemostasis
时间窗: 3 minutes after application
次要结局
- Time to haemostasis(measured through to 10 minutes)
研究者
研究点 (2)
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