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
- Conditions
- Tratamiento hemostático de apoyo en pacientes con cirugía programada del corazón, aorta ascendente o arco de la aorta, que requiera un procedimiento de circulación extracorpórea.Supportive haemostatic treatment in patients having elective surgery on the heart, the ascending aorta or arch, requiring pulmonary bypass procedure.
- Registration Number
- EUCTR2006-000028-15-ES
- Lead Sponsor
- ycomed Danmark ApS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1200
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 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate efficacy and safety of Tachosil in cardiovascular surgery. ;Secondary Objective: Not applicable;Primary end point(s): Proportion of patients achieving haemostasis after 3 minutes
- Secondary Outcome Measures
Name Time Method