TachoSil Paediatric Liver Trial (TC-019-IN)

NCT ID: NCT00365248

Last Updated: 2012-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2008-05-31

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.

Conditions

Liver Diseases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Fibrinogen human (TachoSil)

Resection of the liver with or without segmental liver transplantation

Intervention Type: DRUG

Eligibility Criteria

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)?

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?

• Minimum Eligible Age: 4 Weeks
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nycomed

INDUSTRY

Sponsor Role: lead

Responsible Party

Nycomed

Principal Investigators

Clinical Trial Operations

Role: STUDY_CHAIR

Headquaters

Locations

Nycomed

Roskilde, , Denmark

Countries

Denmark

Other Identifiers

2004-005028-42

Identifier Type: -

Identifier Source: secondary_id

TC-019-IN

Identifier Type: -

Identifier Source: org_study_id