TASALL - TachoSil® Against Liquor Leak
Condition: Cerebrospinal Fluid Leaks
MeSH terms: Cerebrospinal Fluid Leak
Intervention: TachoSil®; Current Practice
Intervention description: 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.; 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®.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 726.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CSF leaks; Skull base surgery; pseudomeningocele; TachoSil®; Prevention; post-operative

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?