NCT01192022已完成3 期
A Randomized, Open Label, Parallel-group, Multi-center Trial to Compare the Efficacy and Safety of TachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery
Takeda17 个研究点 分布在 1 个国家目标入组 253 人开始时间: 2010年8月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 253
- 试验地点
- 17
- 主要终点
- Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes
研究概览
简要总结
The efficacy and safety of TachoSil® as secondary hemostatic treatment in hepatic resection surgery will be compared to the standard USA licensed hemostatic agent, Surgicel® Original. Hemostatic efficacy will be evaluated intraoperatively after application of randomized treatment.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Resection of at least the equivalent tissue volume of 1 anatomical segment of the liver
- •Minor to moderate (oozing/diffuse) bleeding from the resection area persisting after conventional resection procedure and primary control of arterial pulsating bleeding or major venous hemorrhage by sutures, ligations, clips, vascular stapler, point electrocautery or focal radiofrequency ablation
- •Need for additional supportive hemostatic treatment
- •Expected ability to lightly press the trial treatment to the liver resection wound for 3 minutes
排除标准
- •Indication for emergency surgery
- •Known coagulopathy (as judged relevant by the investigator)
- •Known or suspected hypersensitivity to any ingredient of the investigational medicinal products (e.g. human fibrinogen, human thrombin and/or collagen of any origin)
- •Patient unwilling to receive blood products
- •Known current alcohol or drug abuse
- •Pregnancy, breastfeeding, no use of acceptable contraceptive method in females of childbearing potential
- •Dry surgical field of the targeted application area
- •Occurrence of any serious surgical complication
- •Disseminated intravascular coagulopathy (DIC), i.e. microvascular bleeding
- •Application of topical hemostatic material on the liver resection wound
- •Radiofrequency precoagulation of the liver resection wound except focal radiofrequency ablation of vessels as primary hemostatic treatment
结局指标
主要结局
Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes
时间窗: within 3 minutes
3 Minutes after the patch was applied to the target bleeding area, the area was observed to see if the bleeding stopped.
次要结局
- Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 5 Minutes(within 5 minutes)
- Time to Intraoperative Hemostasis at Target Bleeding Site(10 minutes)
研究者
研究点 (17)
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