临床试验/NCT01158261

NCT01158261已完成不适用

A Prospective, Single-Arm, Observational, Non-interventional Study for EVICEL ™ Fibrin Sealant (Human) When Used as an Adjunct to Haemostasis in Vascular Surgery

Ethicon, Inc.2 个研究点分布在 1 个国家目标入组 300 人开始时间: 2010年6月最近更新: 2015年8月19日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Ethicon, Inc.
入组人数: 300
试验地点: 2
主要终点: Specific Safety Parameters

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objective of this non-interventional Post Authorisation Safety Surveillance (PASS) study is to observe the clinical safety performance of EVICEL when used as suture support for haemostasis in vascular surgery.

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

•Subjects, 18 years or older, requiring elective, primary or repeat vascular procedures with at least one end-to-side anastomosis to the femoral artery or to an upper extremity artery
•EVICEL Fibrin Sealant is used as an adjunct to obtain haemostasis at a target anastomosis/es
•Subjects must be willing to and capable of participating in the study, and provide written informed consent

排除标准

•Subjects with known intolerance to blood products
•Subjects unwilling to receive blood products
•Subjects with any intra-operative findings that may preclude the use of a fibrin sealant to control suture line anastomotic bleeding
•Subject participating in another study with an investigational (pre-approved) drug or device within 30 days of surgery

结局指标

主要结局

Specific Safety Parameters

时间窗: Up to 4-weeks post-operatively

* Incidence of graft occlusion * Incidence of adverse events potentially related to non-graft thrombotic events * Incidence of bleeding events

次要结局

未报告次要终点

研究者

发起方

Ethicon, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (2)

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