A Phase III Randomized, Controlled, Superiority Study Evaluating EVARREST™ Fibrin Sealant Patch Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Hepatic Surgery

Ethicon Inc., a Johnson & Johnson Co.0 个研究点目标入组 90 人开始时间: 2013年8月13日最近更新: 2017年4月3日

适应症

试验速览

暂无简介。

•1.Subjects > 18 years of age, requiring elective or urgent, open hepatic surgery.
•2. Presence of an appropriate bleeding hepatic parenchymal Target Bleeding Site (TBS) as identified intra-operatively by the surgeon;
•3. Subjects must be willing to participate in the study, and provide written informed consent
•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 45
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 45

•1.Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure;
•2.TBS is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of EVARREST™ to blood flow and pressure during healing and absorption of the product;
•3. TBS with major arterial bleeding requiring suture or mechanical ligation;
•4. Subjects admitted for trauma surgery;
•5. Subject is a transplant patient for fulminant hepatic failure
•6. Subject with TBS within an actively infected field;
•7. Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine;
•8. Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products;
•9. Subjects who are known, current alcohol and / or drug abusers;
•10. Subjects who have participated in another medical device or investigational drug trial within 30 days of surgery;
•11. Female subjects who are pregnant or nursing.

发起方

Ethicon Inc., a Johnson & Johnson Co.