TASALL - TachoSil® Against Liquor Leak

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01355627
First received: May 11, 2011
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Cerebrospinal Fluid Leaks
Procedure: TachoSil®
Procedure: Current Practice
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Percentage of Participants With Clinically Evident Verified Post-Operative Cerebrospinal Fluid Leak or Clinically Evident Pseudomeningocele or Treatment Failure [ Time Frame: Up to 8 Weeks (7 Weeks ± 1 Week) ] [ Designated as safety issue: No ]
    An assessment was performed daily from randomization to Day of Discharge and at the Efficacy Follow-up visit at week 7 ± 1 week. Clinically evident cerebrospinal fluid leak was confirmed by: 1. Glucose concentration test and/or 2. β-2-transferrin test. A clinically evident pseudomeningocele was considered to be present post-operatively if the following criteria were fulfilled: 1. A subcutaneous, visible/palpable fluctuant fluid accumulation was noted at the site of the surgical incision or adjacent to it; 2. It is suspected the fluid accumulation is cerebrospinal fluid. A treatment failure was defined as application of a new and/or different treatment after application of the study treatment or a third application of (or part of) the selected study treatment on the outside of the dura.


Secondary Outcome Measures:
  • Percentage of Participants With Post-Surgical Non-Clinically Evident Post-Operative Pseudomeningocele [ Time Frame: 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) ] [ Designated as safety issue: No ]
    Non-clinically evident pseudomeningocele was defined as a cerebrospinal fluid accumulation found on a postoperative computerized tomography (CT) or magnetic resonance imaging (MRI) scan which fulfilled the following criteria according to the radiologist assessment before Day of Discharge: CT Scan-Fluid accumulation seen as Hypodense signal, MRI Scan-Fluid accumulation seen as Hypointense signal in T1-weighted image and/ OR Fluid accumulation seen as Hyperintense signal in T2-weighted image.


Enrollment: 726
Study Start Date: April 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TachoSil® Procedure: 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.
Active Comparator: Current practice group Procedure: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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?
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01355627

  Show 39 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Study Chair: Nycomed Clinical Trial Operations
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01355627     History of Changes
Other Study ID Numbers: TC-2402-038-SP
Study First Received: May 11, 2011
Results First Received: June 26, 2014
Last Updated: June 26, 2014
Health Authority: Austria: Ethikkommission
Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Greece: National Organization of Medicines
Italy: The Italian Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ethics Committee
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Regional Ethical Review Board

Keywords provided by Takeda:
CSF leaks
Skull base surgery
pseudomeningocele
TachoSil®
Prevention
post-operative

Additional relevant MeSH terms:
Cerebrospinal Fluid Rhinorrhea
Neurologic Manifestations
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Signs and Symptoms
Wounds and Injuries

ClinicalTrials.gov processed this record on October 19, 2014