EUCTR2006-000028-15-ES进行中（未招募）1 期
Estudio aleatorizado, abierto, de grupos paralelos, multicéntrico, que compara la eficacia y la seguridad de TachoSil frente al tratamiento hemostático estándar en cirugía cardiovascularA randomised, open label, parallel-group, multi-centre trial to compare the efficacy and safety of TachoSil versus standard haemostatic treatment in the cardiovascular surgery - TachoSil versus standard haemostatis treatment of haemorrhage in cardiovascular surgery
ycomed Danmark ApS0 个研究点目标入组 1,200 人开始时间: 2010年3月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Informed consent given.
- •2) Negative pregnancy test for females.
- •3)Use of adequate contraception for females of child-bearing potential.
- •4) Age - at least 18 years old.
- •5) Planned elective surgery on the heart, the ascending aorta or arch, requiring cardiopulmonary procedure.
- •Intra operative:
- •6) Bleeding from the heart muscle, the pericardium, a major vessel or a vascular bed that requires supportive haemostatic treatment
- •7) Identification of target area
- •8) Possibility of compression for 3 minutes
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Participation in any other trial with investigational drug or device within 30 days before inclusion in this trial.
- •2) Participation in a clinical trial concomitantly with the present trial.
- •3) Patient undergoing emergency operation.
- •4) History of allergic reactions after application of human fibrinogen, human thrombin and/or collagen of any origin.
- •5) Suffering from known coagulopathy.
- •6) Currently participation or previously participation in the trial.
- •7) Pregnant or breast feeding females.
- •Intra operative:
- •8) Application of liquid fibrin sealant/glue.
- •9) Disseminated intravascular coagulation (DIC), i.e. micro vascular bleeding.
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