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. - TASALL -TachoSil Against Liquor Leak

• Conditions: Skull base surgery for the prevention of postoperative cerebrospinal fluid (CSF) leaks; MedDRA version: 14.1Level: PTClassification code 10064518Term: Cranial operationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2009-013056-71-IT
• Lead Sponsor: ycomed Danmark ApS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-13
• Last Update Posted: 23 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 726

Inclusion Criteria

Key inclusion criteria â?? positive response required for inclusion: • Is the surgical approach/procedure consistent with skull base surgery? I.e. one of the following: a. Lateral approach to the foramen magnum: Far lateral, extreme lateral, anterolateral, posterolateral b. Approach to the jugular foramen: Infratemporal, juxta condylar, transjugular c. Approach to the cerebello pontine (CP) angle and petrous apex retrosigmoid, translabyrinthine, retrolabyrinthine, transcochlear (limited transpetrosal) d. Approach to the middle fossa: Subtemporal (+/- petrous apex drilling), pterional approach (any fronto temporal approach +/- orbitozygomatic deposition) e. Approach to the anterior fossa: Subfrontal (uni or bilateral) f. Approach to the midline posterior fossa For a complete list of inclusion criteria, please refer to the study protocol.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Key exclusion criteria â?? negative response required for inclusion: • Has the patient been subject to neurosurgery within the last 3 months? • Is the patient anticipated to undergo any additional neurosurgery 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 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 â?? transfacial approaches with wide defect in the skull base? I.e. any of the following: g. Trans basal approach h. Total petrosectomy i. Trans facial approach j. Trans sphenoidal approach k. Endoscopic procedures l. Trans oral approach (and any extension: Le Fort, mandibulotomy) • Does the patient have more than one dura lesion (not including dura lesions from extraventricular or lumbar drains)? For a complete list of exclusion criteria, please refer to the study protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified