TachoSil Paediatric Liver Trial (TC-019-IN)

This study has been completed.
Sponsor:
Information provided by:
Nycomed
ClinicalTrials.gov Identifier:
NCT00365248
First received: August 16, 2006
Last updated: May 4, 2012
Last verified: July 2008
  Purpose

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.


Condition Intervention Phase
Liver Diseases
Drug: Fibrinogen human (TachoSil)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Nycomed:

Primary Outcome Measures:
  • 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. [ Time Frame: 7½ months ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: October 2005
Study Completion Date: May 2008
Intervention Details:
    Drug: Fibrinogen human (TachoSil)
    Resection of the liver with or without segmental liver transplantation
  Eligibility

Ages Eligible for Study:   up to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)?

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".
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00365248

Locations
Denmark
Nycomed
Roskilde, Denmark, 4000
Sponsors and Collaborators
Nycomed
Investigators
Study Chair: Clinical Trial Operations Headquaters
  More Information

No publications provided

Responsible Party: Nycomed
ClinicalTrials.gov Identifier: NCT00365248     History of Changes
Other Study ID Numbers: TC-019-IN, 2004-005028-42
Study First Received: August 16, 2006
Last Updated: May 4, 2012
Health Authority: United Kingdom: National Health Service

Keywords provided by Nycomed:
Surgical resection of the liver with or without segmental transplantation

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 23, 2014