NCT02284256已完成3 期
A Phase 3b, Randomized, Single-Blind, Controlled, Comparative Efficacy and Safety Study of Topical FibrocapsTM (RaplixaTM) and Tachosil® in Surgical Hemostasis During Hepatic Resection
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mallinckrodt
- 入组人数
- 150
- 试验地点
- 15
- 主要终点
- Time to Hemostasis (TTH)
研究概览
简要总结
The primary objective of the study is to demonstrate the non-inferiority or superiority of Fibrocaps plus gelatin sponge compared to Tachosil when control of mild to moderate bleeding with conventional surgical techniques is ineffective or impractical.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Subject has known hypersensitivity to Fibrocaps or any of its components
- •Subject has known allergy to porcine gelatin
- •Subject has known hypersensitivity to Tachosil or any of the excipients included in Tachosil
- •Subject is unwilling to receive blood products
- •Subject is having hepatic surgery due to emergency-traumatic event
- •Subject requires extrahepatic bile duct resection (common bile duct resection or resection of the bile duct which leads to performing an anastomoses between the bile duct and small bowel) and biliary anastomosis, and/or pancreatic resections
- •Subject has any clinically-significant coagulation disorder that may interfere with the assessment of efficacy or pose a safety risk to the subject according to the investigator, or baseline abnormalities of international normalized ratio (INR) > 2.5 or activated partial thromboplastin time (aPTT) > 100 seconds during screening that are not explained by current drug treatment (e.g., warfarin, heparin)
- •Subject has a platelet count < 100 x10^9 PLT/L during screening
- •Subject has medical, social or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures
- •Subject is currently participating or has participated in another clinical study involving another investigational agent within 4 weeks of the planned date of surgery or is planning participation in another clinical trial within 6 weeks after surgery
研究组 & 干预措施
Fibrocaps
Experimental
Human fibrinogen and thrombin powder. Single application during surgery
Other Names:
- Raplixa
- PRO-0601
- Fibrin sealant
Device: Gelatin sponge. Single application during surgery
Other Name: Spongostan
干预措施: Fibrocaps (Drug)
TachoSil
Active Comparator
Human fibrinogen and thrombin powder. Single application during surgery
干预措施: TachoSil (Drug)
结局指标
主要结局
Time to Hemostasis (TTH)
时间窗: Within 5 minutes of treatment
次要结局
未报告次要终点
研究者
研究点 (15)
Loading locations...
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