TachoSil Paediatric Liver Trial (TC-019-IN)
NCT00365248 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2012-05-07
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
Interventions
- DRUG
-
Fibrinogen human (TachoSil)
Resection of the liver with or without segmental liver transplantation
Sponsors & Collaborators
-
Nycomed
lead INDUSTRY
Principal Investigators
-
Clinical Trial Operations · Headquaters
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 4 Weeks
- Max Age
- 6 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-10-31
- Completion
- 2008-05-31
Countries
- Denmark
Study Locations
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