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 - TachoSil paediatric liver study
Active, not recruiting
- Conditions
- Paediatric patients (age above 4 weeks and below 6 years) undergoing surgical resection of the liver with or without segmental liver transplantation
- Registration Number
- EUCTR2004-005028-42-GB
- Lead Sponsor
- ycomed Danmark ApS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Infomed consent obtained from the parents(s)/legal gurdian.
Minor or moderate haemorrhage from the cut surface after liver resection with or without segmental liver transplantation and after primary haemostatic treatment. Age above 4 weeks and below 6 years.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Congenital coagulation disorders. Serious surgical complications. Hypersensitivity to the active substances or to any of the excipients.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method