A Phase 3, Stratified Randomized, Double-blind, Placebo-controlled Study of Topical Recombinant Human Thrombin (rhThrombin) in Surgical Hemostasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 348
- 试验地点
- 1
- 主要终点
- The rate of complete hemostasis within 6 minutes.
研究概览
简要总结
A multicenter, stratified randomized, double-blind, placebo-controlled, phase 3 clinical trial.
详细描述
After establishing eligibility, subjects will be randomized in a 2:1 ratio to receive rhThrombin (1000 U/mL) or placebo. During a surgical procedure, study participants will be treated with blinded study drug (rhThrombin or placebo) in combination with an absorbable gelatin sponge at appropriate bleeding evaluation site(s). 510 patients will participate in the study.
In this study, stratified random enrollment was conducted according to the condition(experimental group or control group) of the subjects.Stratification factors were centered, gender (male/female) and age (18 ≤ age <60/60 ≤ age ≤70).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 70 years old (including 18 and 70 years old), male or female;
- •Patients with wedge-shaped liver resection or anatomical liver resection(1-5 consecutive liver segments);
- •After the operation was controlled by standard surgical hemostasis, there were still patients with mild/moderate bleeding lesions (bleeding, non-arterial bleeding);
- •Electrolytes (K, Na, CL, Ca, P, Mg) and ECG are normal or abnormal, Investigators believe that patients who do not affect surgery
- •No other therapeutic surgery within 4 weeks before enrollment;
- •Patients who have not used blood products within 24 hours before surgery;
- •In compliance with the requirements of the ethics committee, patients voluntarily signed informed consent and were able to conduct visits as required by the protocol.
排除标准
- •Known diseases of the blood system, including patients with coagulopathy or bleeding tendency;
- •Patients with unstable vital signs for more than 24 hours;
- •A history of severe heart, brain, and vascular disease within 6 months, including patients with a history of TIA, non-disabling cerebral infarction, myocardial infarction, unstable angina, or intracranial hemorrhage;
- •Active bleeding or abnormal coagulation function (PT>16s, APTT>43s, INR≥2) or receiving thrombolysis, anticoagulation or antiplatelet therapy;
- •Have used drugs that affect the function of the coagulation system within 1 week before surgery (including but not limited to: aspirin, clopidogrel, ticlopidine, fensulfamide, desmopressin, aminotoluic acid, dipyridamole, ginkgo Leaf preparations, heparin, warfarin, citrate, hemagglutinin, Vk, anti-fibrotic solvents, hemostatic, Vc, etc.);
- •Women during pregnancy and lactation;
- •Participants who participated in clinical trials of other drugs within 4 weeks before enrollment.
研究组 & 干预措施
The experimental group
The topical recombinant human thrombin(rhThrombin) was prepared into 1000IU/mL solution with 10ml normal saline and used in combination with absorbable gelatin spongeat at appropriate bleeding evaluation site(s).
干预措施: recombinant human Thrombin(CHO cell) (Biological)
The control group
The placebo was prepared into a solution with 10mL normal saline and used in combination with absorbable gelatin sponge at appropriate bleeding evaluation site(s).
干预措施: placebo (Biological)
结局指标
主要结局
The rate of complete hemostasis within 6 minutes.
时间窗: 6 minutes
Those who did not stop bleeding within 6 minutes were defined as treatment failure.
次要结局
- Time to Hemostasis(TTH)(Evaluate the effect of hemostasis every 30sec until hemostasis is completed or 6 minutes of observation is completed)
- Immunogenicity(At baseline and Day 29)
- Incidence of adverse events(AE)(Up to 28 days)