Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
726 participants
INTERVENTIONAL
2011-04-30
2013-06-30
Brief Summary
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The trial population will consist of 726 randomised (1:1) patients elected for skull base surgery. The trial duration consists of screening, surgery, efficacy follow-up after 7±1 weeks and safety follow-up 28±2 weeks after surgery.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TachoSil®
TachoSil®
Primary suture must be performed. Duraplasty may be performed at the discretion of the investigator. TachoSil® must be applied under aseptic conditions during the closure of the dura.
Current practice group
Current Practice
Primary suture must be performed. Duraplasty may be performed at the discretion of the investigator.
In addition to primary suture, whatever means of dura closure deemed necessary by the investigator may be used with the exception of TachoSil®.
Interventions
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TachoSil®
Primary suture must be performed. Duraplasty may be performed at the discretion of the investigator. TachoSil® must be applied under aseptic conditions during the closure of the dura.
Current Practice
Primary suture must be performed. Duraplasty may be performed at the discretion of the investigator.
In addition to primary suture, whatever means of dura closure deemed necessary by the investigator may be used with the exception of TachoSil®.
Eligibility Criteria
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Inclusion Criteria
* Lateral approach to the foramen magnum: Far lateral, extreme lateral, anterolateral, posterolateral
* Approach to the jugular foramen: Infratemporal, juxta condylar, transjugular
* Approach to the cerebello pontine (CP) angle and petrous apex retrosigmoid
* Approach to the middle fossa: Subtemporal (+/- petrous apex drilling), pterional approach (any fronto temporal approach +/- orbitozygomatic deposition)
* Approach to the anterior fossa: Subfrontal (uni or bilateral)
* Approach to the midline posterior fossa
Exclusion Criteria
* Is the patient anticipated to undergo any additional neurosurgery involving opening of the dura mater which may affect the efficacy evaluation (e.g. re-operation or anticipation to undergo several neurosurgeries) before the Efficacy Follow-up Week 7±1 week?
* Is the patient anticipated to undergo any additional neurosurgery involving opening of the dura mater which may affect the safety evaluation (e.g. re-operation or anticipation to undergo several neurosurgeries) before the Safety Follow-up Week 28±2 weeks?
* The surgical approach/procedure is consistent with any transcranial or transfacial or combination of transcranial - transfacial approaches with wide defect in the skull base? I.e. any of the following:
* Trans basal approach
* Total petrosectomy
* Trans facial approach
* Trans sphenoidal approach
* Endoscopic procedures
* Trans oral approach (and any extension: Le Fort, mandibulotomy)
* The surgical approach is consistent with one of the following approaches?
* Translabyrinthine approach
* Retrolabyrinthine approach
* Transcochlear (limited transpetrosal) approach
* Did the arachnoid membrane and the CSF containing system remain intact during surgery?
* Does the patient have more than one dura opening (not including dura openings from extraventricular or lumbar drains)?
* Has TachoSil, fibrin or polymer sealants been used during the current surgery prior to randomization?
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Nycomed
Role: STUDY_CHAIR
Clinical Trial Operations
Locations
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Nycomed Investigational Site
Graz, , Austria
Nycomed Investigational Site
Brussels, , Belgium
Nycomed Investigational Site
Genk, , Belgium
Nycomed Investigational Site
Leuven, , Belgium
Nycomed Investigational Site
Liège, , Belgium
Nycomed Investigational Site
Grenoble, , France
Nycomed Investigational Site
Le Kremlin-Bicêtre, , France
Nycomed Investigational Site
Marseille, , France
Nycomed Investigational Site
Nice, , France
Nycomed Investigational Site
Paris, , France
Nycomed Investigational Site
Strasbourg, , France
Nycomed Investigational Site
Toulouse, , France
Nycomed Investigational Site
Freiburg im Breisgau, , Germany
Nycomed Investigational Site
Halle, , Germany
Nycomed Investigational Site
Homburg, , Germany
Nycomed Investigational Site
München, , Germany
Nycomed Investigational Site
Rostock, , Germany
Nycomed Investigational Site
Athens, , Greece
Nycomed Investigational Site
Athens, , Greece
Nycomed Investigational Site
Thessaloniki, , Greece
Nycomed Investigational Site
Genova, , Italy
Nycomed Investigational Site
Lecce, , Italy
Nycomed Investigational Site
Palermo, , Italy
Nycomed Investigational Site
Siena, , Italy
Nycomed Investigational Site
Dammers, , Netherlands
Nycomed Investigational Site
Gdansk, , Poland
Nycomed Investigational Site
Gdansk, , Poland
Nycomed Investigational Site
Warsaw, , Poland
Nycomed Investigational Site
Moscow, , Russia
Nycomed Investigational Site
Barcelona, , Spain
Nycomed Investigational Site
Barcelona, , Spain
Nycomed Investigational Site
El Palmar, , Spain
Nycomed Investigational Site
Madrid, , Spain
Nycomed Investigational Site
Majadahonda, , Spain
Nycomed Investigational Site
Málaga, , Spain
Nycomed Investigational Site
Santiago de Compostela, , Spain
Nycomed Investigational Site
Gothenburg, , Sweden
Nycomed Investigational Site
Lund, , Sweden
Nycomed Investigational Site
Stockholm, , Sweden
Countries
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Other Identifiers
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TC-2402-038-SP
Identifier Type: -
Identifier Source: org_study_id
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