NCT00440401已完成4 期
A Randomised, Open Label, Parallel-group, Multi-centre Trial to Compare the Efficacy and Safety of TachoSil® Versus Standard Haemostatic Treatment in Cardiovascular Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Nycomed
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Proportion of Subjects Achieving Haemostasis at 3 Minutes
研究概览
简要总结
To demonstrate efficacy and safety of TachoSil® in cardiovascular surgery
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
- 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
- •All inclusion criteria must be answered "yes" for a subject to participate in the trial.
- •At Screening:
- •Has the subject given informed consent according to local requirements before any trial related activities? A trial related activity is any procedure that would not have been performed during the routine management of the subject. In this trial the screening is the first trial related activity.
- •For female subjects of childbearing potential: Is the pregnancy test at screening negative?
- •Does the female subject of childbearing potential use adequate contraception (contraceptive pill, contraceptive injection, contraceptive implant or intrauterine device)?
- •Is the subject ≥ 18 years of age?
- •Is the following planned: An elective surgery on the heart, the ascending aorta or arch, requiring cardiopulmonary bypass procedure?
- •Intra operative (after primary haemostatic treatment):
- •Is bleeding from the heart muscle, the pericardium, a major vessel or a vascular bed that requires supportive haemostatic treatment present?
- •Has the area with the most problematic haemorrhage (target area) been identified? (please note that this must be done before randomisation).
- •Is it possible to compress the randomised treatment (TachoSil® or control fleece material) for 3 minutes?
排除标准
- •All exclusion criteria must be answered "no" for a subject to participate in the trial.
- •At Screening:
- •Has the subject participated in any other trial with an investigational drug or device within 30 days before inclusion in this trial?
- •Does the subject participate in a clinical trial concomitantly with the present trial?
- •Is the subject undergoing an emergency operation?
- •Has the subject a history of allergic reactions after application of human fibrinogen, human thrombin and/or collagen of any origin?
- •Is the subject suffering from known coagulopathy?
- •Is the subject currently participating or has the subject previously participated in the TC-023-IM trial?
- •Is the female subject pregnant or breast feeding?
- •Intra operative (after primary haemostatic treatment):
- •Has liquid fibrin sealant/glue or TachoSil® been applied?
- •Has the following occurred: Disseminated intravascular coagulation (DIC), i.e. micro vascular bleeding?
研究组 & 干预措施
TachoSil®
Active Comparator
干预措施: fibrinogen (human) + thrombin (human) (Drug)
Standard Treatment
Active Comparator
Standard Treatment of haemorrhage in cardiovascular surgery
干预措施: Standard haemostatic treatment in cardiovascular surgery (Drug)
结局指标
主要结局
Proportion of Subjects Achieving Haemostasis at 3 Minutes
时间窗: 3 minutes
Three minutes after application of trial treatment (TachoSil® or standard fleece material) the investigator evaluated if haemostasis in the target area was achieved.
次要结局
- Proportion of Subjects Achieving Haemostasis at 6 Minutes.(6 minutes)
研究者
研究点 (1)
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