EUCTR2013-003464-31-BE进行中（未招募）不适用
A Single-blinded, Randomized, Controlled, Comparative Phase III Study Evaluating the Safety and Effectiveness of EVARREST™ Fibrin Sealant Patch as an Adjunct to Hemostasis During Cardiovascular Surgery
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Ethicon Inc
- 入组人数
- 210
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Pre-Operative
- •1. Subjects =18 years of age, requiring an elective or urgent, open aortic
- •surgical procedure utilizing cardiopulmonary bypass;
- •a. Subjects in Japan between =18 and <20 years of age will require consent by the subject’s legal representative
- •2. Subjects must be willing to participate in the study and provide written informed consent.
- •Intra-Operative
- •1. Presence of an appropriate Target Bleeding Site along the anastomotic
- •suture line, involving a synthetic aortic graft, as identified intraoperatively
- •by the investigator;
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 105
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 105
排除标准
- •Pre-Operative
- •1. Subjects with known intolerance to blood products or to one of the
- •components of the study product or unwilling to receive blood
- •2. Exposure to another investigational drug or device in a clinical trial
- •within 30 days prior to surgery or anticipated in the 60 day follow up
- •period after surgery.
- •3. Female subjects who are pregnant or nursing.
- •Intra-Operative
- •1. TBS is from a large defects in visible arteries or veins where the injured
- •vascular wall requires repair and maintenance of vessel patency or
- •where there would be persistent exposure of EVARREST™ Fibrin Sealant
- •Patch to blood flow and/or pressure during absorption of the product;
- •2. TBS with major arterial bleeding requiring suture or mechanical ligation;
- •3. TBS involves an expanded polytetrafluoroethylene (ePTFE) graft
- •4. TBS within an actively infected field;
- •5. Bleeding site is in, around, or in proximity to foramina in bone, or areas
- •of bony confine;
- •6. Subjects with any intra-operative findings identified by the investigator
- •that may preclude conduct of the study procedure;
研究者
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