Paediatric patients (age above 4 weeks and below 6 years) undergoing surgical resection of the liver with or without segmental liver transplantation
Conditions
Sponsors
Nycomed Danmark ApS
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Congenital coagulation disorders. Serious surgical complications. Hypersensitivity to the active substances or to any of the excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: (The paediatric trial was requested by the CHMP) Assessement of the haemostatic efficacy and safety of TachoSil for control of intra-operational local bleeding in paediatric patients undergoing surgical resection of the liver with or without segmental liver transplantation. ;Secondary Objective: Not applicable;Primary end point(s): The primary (and only) efficacy endpoint is the overall time (min) to intra-operative haemostasis from the time TachoSil is applied. A 6 months safety follow-up is performed (required by CHMP). | — |
Countries
United Kingdom
Outcome results
None listed