A 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: 2006年12月11日最近更新: 2021年10月8日

适应症

试验速览

暂无简介。

•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

•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 fibrinoge, 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.

发起方

ycomed Danmark ApS