TachoSil Paediatric Liver Trial (TC-019-IN)
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.
2 other identifiers
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2005
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 16, 2006
CompletedFirst Posted
Study publicly available on registry
August 17, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedMay 7, 2012
July 1, 2008
August 16, 2006
May 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Interventions
Resection of the liver with or without segmental liver transplantation
Eligibility Criteria
You may qualify if:
- 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)?
You may not qualify if:
- 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?
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nycomedlead
Study Sites (1)
Nycomed
Roskilde, 4000, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Clinical Trial Operations
Headquaters
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 16, 2006
First Posted
August 17, 2006
Study Start
October 1, 2005
Study Completion
May 1, 2008
Last Updated
May 7, 2012
Record last verified: 2008-07