TASALL - TachoSil® Against Liquor Leak - Full Text View

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:

Drug Information available for: TachoSil

U.S. FDA Resources

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:

To evaluate the occurrence of a clinically evident cerebrospinal fluid leak or clinically evident pseudomeningocele [ Time Frame: Up to 7 weeks ] [ Designated as safety issue: No ]
The assessment will be 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 will be confirmed by
1. Glucose concentration test and/or
2. β-2-transferrin test
A clinically evident pseudomeningocele must be considered to be present post-operatively if the following criteria are fulfilled
1. A subcutaneous, visible/palpable fluctuant fluid accumulation is noted at the site of the surgical incision or adjacent to it
2. It is suspected the fluid accumulation is cerebrospinal fluid

Secondary Outcome Measures:

To evaluate the occurrence of non-clinical evident pseudomeningocele [ Time Frame: The participants will be assessed at least once prior to discharge from neurosurgical ward, with the expected discharge from neurosurgical ward after an average of 10 days ] [ Designated as safety issue: No ]
The secondary outcome measure is non-clinical evident pseudomeningocele only found at a post-operative scan until the Day of Discharge defined as a cerebrospinal fluid accumulation only found on a postoperative CT or MRI scan which fulfill 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

Estimated Enrollment:	726
Study Start Date:	April 2011
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	April 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

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

Contacts

Contact: Takeda Study Registration Call Center

+1-800-778-2860

ormation@tpna.com

Show 39 Study Locations

Sponsors and Collaborators

Nycomed: A Takeda Company

Investigators

Study Chair:

Nycomed

Clinical Trial Operations

More Information

No publications provided

Responsible Party:	Takeda Global Research & Development Center, Inc. ( Nycomed: A Takeda Company )
ClinicalTrials.gov Identifier:	NCT01355627 History of Changes
Other Study ID Numbers:	TC-2402-038-SP
Study First Received:	May 11, 2011
Last Updated:	October 18, 2012
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 Global Research & Development Center, Inc.:

CSF leaks
Skull base surgery
pseudomeningocele

TachoSil®
Prevention
post-operative

Additional relevant MeSH terms:

Cerebrospinal Fluid Rhinorrhea
Intracranial Hypotension
Neurologic Manifestations
Nervous System Diseases
Craniocerebral Trauma

Trauma, Nervous System
Signs and Symptoms
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013