TachoSil Paediatric Liver Trial (TC-019-IN)

Inclusion criteria

• Has the parent(s)/legal guardian given informed consent according to local requirements before any trial related activities?
• Is the child above 4 weeks and below 6 years of age?
• 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?
• 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

• Was the child retransplanted or had liver transplantation in combination with other organs?
• Was there anamnestic or laboratory evidence of congenital coagulation disorders including Haemophilia A or B and von Willebrand disease?
• Has the child a history of allergic reactions after application of human fibrinogen, human thrombin and/or collagen of any origin?
• 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?
• Did the child undergo an emergency operation?
• Does the child participate in another clinical trial during the intra-operative phase?
• Has any serious surgical complication occurred?
• 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 exclusion criteria must be answered "No" for a child having segmental resection. For a child having total hepatectomy and placement of a segmental liver transplant criteria 4 and 5 can be answered "Yes".