A prospective, multicenter, single-blind, randomized, active-controlled, non-inferiority pivotal study to evaluate the safety and efficacy of Stopad versus Tachosil in patients with oozing after primary control of bleeding by standard techniques (such as sutures, ligatures, clips, vascular stapler, electrocautery, local radiofrequency ablation) in open hepatic resection

BioBud0 个研究点目标入组 104 人开始时间: 待定最近更新: 2019年11月5日

适应症

试验速览

暂无简介。

•1. Adults over 19
•2. Those who need a hepatic treatment for hepatic cancer, hepatic carcinoma, hepatic gallbladder cancer, metastatic liver cancer, and benign liver tumor
•3. If an arterial beat hemorrhage or major venous hemorrhage persists after an open surgery after haemostasis by the primary haemostasis method (such as sutures, adhesives, vascular clips, vascular staplers, electrocautery, local high frequency resection, etc.)
•4. A person who voluntarily decides and agrees to participate in this clinical trial

•1. Those who need emergency liver resection
•2. In case participation in this clinical trial is not appropriate at the discretion of the Investigator due to coagulation disorder
•3. Allergic or overreactive to Chitosan, Crustaceans, Batroxobin, anti-human lymphocytes Ig, Anti-thymocyre globulin, Freeze-dried Agkistrodon anti venom.
•4. Drug abuse or alcoholism
•5. Pregnant, nursing, or women planning to conceive within the clinical trial period or who do not agree with the proper use of contraceptives
•6. In case of serious surgical complications during surgery affecting this clinical trial assessment by the Invester's judgment
•7. Those currently receiving immunosuppressive treatment
•8. Someone with a history of liver transplants
•9. Participated in clinical trials of medicines or medical devices within one month of screening. However, it is possible to register if the validity and safety evaluation of this clinical trial is not affected by the judgment of the invester.
•10. Other cases where the invester determines that they are not suitable for this clinical trial or may increase the risk associated with participating in the clinical trial.

发起方

BioBud