Phase 3 N=726 Randomized Treatment

TASALL - TachoSil® Against Liquor Leak

Cerebrospinal Fluid Leaks

Bottom Line

View on ClinicalTrials.gov: NCT01355627 ↗

Enrolled (actual)

726

Serious AEs

26.3%

Results posted

Jul 2014

Primary outcome: Primary: Percentage of Participants With Clinically Evident Verified Post-Operative Cerebrospinal Fluid Leak or Clinically Evident Pseudomeningocele or Treatment Failure — 6.9; 8.2 percentage of participants — p=0.485

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: TachoSil® (Procedure); Current Practice (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Takeda
Primary completion: Jun 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Clinically Evident Verified Post-Operative Cerebrospinal Fluid Leak or Clinically Evident Pseudomeningocele or Treatment Failure	6.9; 8.2	0.485
SECONDARY Percentage of Participants With Post-Surgical Non-Clinically Evident Post-Operative Pseudomeningocele	3.0; 3.0	—

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?

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01355627). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.