NCT00365248已完成3 期
A Prospective, Multi-centre Phase III-b Study of TachoSil in Paediatric Patients Scheduled for Resection of the Liver With or Without Segmental Liver Transplantation.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Nycomed
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- The primary objective is to collect data on efficacy, i.e. intra-operative haemostasis, and safety of TachoSil ® as treatment to control local bleeding in children undergoing surgical resection of the liver with or without segmental transplantation.
研究概览
简要总结
The overall objective is to assess the haemostatic efficacy and safety of TachoSil for control of local bleeding in paediatric patients undergoing surgical resection of the liver with our without segmental liver transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Weeks 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has the parent(s)/legal guardian given informed consent according to local requirements before any trial related activities?
- •Is the child above 4 weeks and below 6 years of age?
- •Has at least segmental resection (anatomical/non-anatomical) of the liver and primary haemostatic treatment been performed? or Has resection of the liver and placement of a segmental liver graft and primary haemostatic treatment been performed?
- •Is only minor, i.e. oozing, or moderate haemorrhage persisting after primary surgical haemostatic procedures of the major vessels (no pulsating arterial haemorrhage and/or major venous bleeding)?
- •All inclusion criteria must be answered "yes" for a child to participate in the study.
排除标准
- •Was the child retransplanted or had liver transplantation in combination with other organs?
- •Was there anamnestic or laboratory evidence of congenital coagulation disorders including Haemophilia A or B and von Willebrand disease?
- •Has the child a history of allergic reactions after application of human fibrinogen, human thrombin and/or collagen of any origin?
- •Has the child fulminant hepatic failure, portal vein thrombosis or anamnestic or clinical evidence of cirrhotic condition of the liver, including cirrhosis due to genetic deficiency of a1 - Antitrypsin?
- •Did the child undergo an emergency operation?
- •Does the child participate in another clinical trial during the intra-operative phase?
- •Has any serious surgical complication occurred?
- •Has any fibrin glue haemostatic (including TachoSil ® ) been used on the target wound before the planned application of TachoSil ® ? To participate in the study all exclusion criteria must be answered "No" for a child having segmental resection. For a child having total hepatectomy and placement of a segmental liver transplant criteria 4 and 5 can be answered "Yes".
结局指标
主要结局
The primary objective is to collect data on efficacy, i.e. intra-operative haemostasis, and safety of TachoSil ® as treatment to control local bleeding in children undergoing surgical resection of the liver with or without segmental transplantation.
时间窗: 7½ months
次要结局
未报告次要终点
研究者
研究点 (2)
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