Clinical trial NCT01355627: TASALL - TachoSil® Against Liquor Leak
Official title: TachoSil® Versus Current Practice in Dura Sealing Techniques for the Prevention of Post-operative Cerebrospinal Fluid (CSF) Leaks in Patients Undergoing Skull Base Surgery: An Open Label, Randomised, Controlled, Multi-centre, Parallel Group Efficacy and Safety Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cerebrospinal Fluid Leaks
Keywords: CSF leaks
Skull base surgery
pseudomeningocele
TachoSil®
Prevention
post-operative
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-05-18
Enrollment: 726
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to demonstrate superiority of TachoSil® compared to current practice as an adjunct in sealing the dura mater. The efficacy of the dura mater sealing must be evaluated post-operatively. The secondary objective is to evaluate the safety of TachoSil® as an adjunct in sealing the dura mater.

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.


Eligibility criteria: Main Inclusion Criteria (Positive response):

• Is the surgical approach/procedure consistent with skull base surgery? I.e. one of the following:

* 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

Main Exclusion Criteria (Negative response):

* Has the patient been subject to neurosurgery involving opening of the dura mater within the last 3 months?
* 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?

Primary outcomes:
measure: Percentage of Participants With Clinically Evident Verified Post-Operative Cerebrospinal Fluid Leak or Clinically Evident Pseudomeningocele or Treatment Failure
timeFrame: Up to 8 Weeks (7 Weeks ± 1 Week)
Secondary outcomes:
measure: Percentage of Participants With Post-Surgical Non-Clinically Evident Post-Operative Pseudomeningocele
timeFrame: Assessment at least once prior to discharge from neurosurgical ward, with the expected discharge from neurosurgical ward after an average of 10 days (Up to 28 Weeks)
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Nycomed Investigational Site
city: Brussels
country: Belgium
facility: Nycomed Investigational Site
city: Genk
country: Belgium
facility: Nycomed Investigational Site
city: Leuven
country: Belgium
facility: Nycomed Investigational Site
city: Liege
country: Belgium
facility: Nycomed Investigational Site
city: Grenoble
country: France
facility: Nycomed Investigational Site
city: Le Kremlin Bicetre
country: France
facility: Nycomed Investigational Site
city: Marseille
country: France
facility: Nycomed Investigational Site
city: Nice
country: France
facility: Nycomed Investigational Site
city: Paris
country: France
facility: Nycomed Investigational Site
city: Strassbourg
country: France
facility: Nycomed Investigational Site
city: Toulouse
country: France
facility: Nycomed Investigational Site
city: Freiburg
country: Germany
facility: Nycomed Investigational Site
city: Halle
country: Germany
facility: Nycomed Investigational Site
city: Homburg
country: Germany
facility: Nycomed Investigational Site
city: München
country: Germany
facility: Nycomed Investigational Site
city: Rostock
country: Germany
facility: Nycomed Investigational Site
city: Athens
country: Greece
facility: Nycomed Investigational Site
city: Athens
country: Greece
facility: Nycomed Investigational Site
city: Thessaloniki
country: Greece
facility: Nycomed Investigational Site
city: Genova
country: Italy
facility: Nycomed Investigational Site
city: Lecce
country: Italy
facility: Nycomed Investigational Site
city: Palermo
country: Italy
facility: Nycomed Investigational Site
city: Siena
country: Italy
facility: Nycomed Investigational Site
city: Dammers
country: Netherlands
facility: Nycomed Investigational Site
city: Gdansk
country: Poland
facility: Nycomed Investigational Site
city: Gdansk
country: Poland
facility: Nycomed Investigational Site
city: Warszawa
country: Poland
facility: Nycomed Investigational Site
city: Moscow
country: Russian Federation
facility: Nycomed Investigational Site
city: Barcelona
country: Spain
facility: Nycomed Investigational Site
city: Barcelona
country: Spain
facility: Nycomed Investigational Site
city: El Palmar
country: Spain
facility: Nycomed Investigational Site
city: Madrid
country: Spain
facility: Nycomed Investigational Site
city: Majadahonda
country: Spain
facility: Nycomed Investigational Site
city: Malaga
country: Spain
facility: Nycomed Investigational Site
city: Santiago de Compostela
country: Spain
facility: Nycomed Investigational Site
city: Göteborg
country: Sweden
facility: Nycomed Investigational Site
city: Lund
country: Sweden
facility: Nycomed Investigational Site
city: Stockholm
country: Sweden
facility: Nycomed Investigational Site
Study officials:
affiliation: Clinical Trial Operations
name: Nycomed
role: STUDY_CHAIR
References: