TachoSil Paediatric Liver Trial (TC-019-IN)

Nycomed

Status and phase: Completed; Phase 3

Conditions: Liver Diseases

Treatments: Drug: Fibrinogen human (TachoSil)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00365248

2004-005028-42

TC-019-IN

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 4 weeks to 6 years old

Volunteers: No Healthy Volunteers

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 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".

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)