TachoSil Paediatric Liver Trial (TC-019-IN)

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Liver Diseases

Intervention / Treatment
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* Drug: Fibrinogen human (TachoSil)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Weeks
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fibrinogen human (TachoSil)|Resection of the liver with or without segmental liver transplantation|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical resection of the liver with or without segmental transplantation