Liver Diseases
Conditions
Keywords
Surgical resection of the liver with or without segmental transplantation
Brief summary
The overall objective is to assess the haemostatic efficacy and safety of TachoSil for control of local bleeding in paediatric patients undergoing surgical resection of the liver with our without segmental liver transplantation.
Interventions
DRUGFibrinogen human (TachoSil)
Resection of the liver with or without segmental liver transplantation
Sponsors
Nycomed
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Weeks to 6 Years
Healthy volunteers
No
Inclusion criteria
1. Has the parent(s)/legal guardian given informed consent according to local requirements before any trial related activities? 2. Is the child above 4 weeks and below 6 years of age? 3. Has at least segmental resection (anatomical/non-anatomical) of the liver and primary haemostatic treatment been performed? or Has resection of the liver and placement of a segmental liver graft and primary haemostatic treatment been performed? 4. Is only minor, i.e. oozing, or moderate haemorrhage persisting after primary surgical haemostatic procedures of the major vessels (no pulsating arterial haemorrhage and/or major venous bleeding)? All inclusion criteria must be answered yes for a child to participate in the study.
Exclusion criteria
1. Was the child retransplanted or had liver transplantation in combination with other organs? 2. Was there anamnestic or laboratory evidence of congenital coagulation disorders including Haemophilia A or B and von Willebrand disease? 3. Has the child a history of allergic reactions after application of human fibrinogen, human thrombin and/or collagen of any origin? 4. Has the child fulminant hepatic failure, portal vein thrombosis or anamnestic or clinical evidence of cirrhotic condition of the liver, including cirrhosis due to genetic deficiency of a1 - Antitrypsin? 5. Did the child undergo an emergency operation? 6. Does the child participate in another clinical trial during the intra-operative phase? 7. Has any serious surgical complication occurred? 8. Has any fibrin glue haemostatic (including TachoSil ® ) been used on the target wound before the planned application of TachoSil ® ? To participate in the study all
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to collect data on efficacy, i.e. intra-operative haemostasis, and safety of TachoSil ® as treatment to control local bleeding in children undergoing surgical resection of the liver with or without segmental transplantation. | 7½ months |
Countries
Denmark
Outcome results
None listed