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TASALL - TachoSil® Against Liquor Leak

Primary Purpose

Cerebrospinal Fluid Leaks

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TachoSil®
Current Practice
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrospinal Fluid Leaks focused on measuring CSF leaks, Skull base surgery, pseudomeningocele, TachoSil®, Prevention, post-operative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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?

Sites / Locations

  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TachoSil®

Current practice group

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With Clinically Evident Verified Post-Operative Cerebrospinal Fluid Leak or Clinically Evident Pseudomeningocele or Treatment Failure
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
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.

Full Information

First Posted
May 11, 2011
Last Updated
June 26, 2014
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT01355627
Brief Title
TASALL - TachoSil® Against Liquor Leak
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrospinal Fluid Leaks
Keywords
CSF leaks, Skull base surgery, pseudomeningocele, TachoSil®, Prevention, post-operative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
726 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TachoSil®
Arm Type
Experimental
Arm Title
Current practice group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
TachoSil®
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.
Intervention Type
Procedure
Intervention Name(s)
Current Practice
Intervention Description
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®.
Primary Outcome Measure Information:
Title
Percentage of Participants With Clinically Evident Verified Post-Operative Cerebrospinal Fluid Leak or Clinically Evident Pseudomeningocele or Treatment Failure
Description
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.
Time Frame
Up to 8 Weeks (7 Weeks ± 1 Week)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Post-Surgical Non-Clinically Evident Post-Operative Pseudomeningocele
Description
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.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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?
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nycomed
Organizational Affiliation
Clinical Trial Operations
Official's Role
Study Chair
Facility Information:
Facility Name
Nycomed Investigational Site
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Nycomed Investigational Site
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Nycomed Investigational Site
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Nycomed Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Nycomed Investigational Site
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Nycomed Investigational Site
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Nycomed Investigational Site
City
Le Kremlin Bicetre
ZIP/Postal Code
94270
Country
France
Facility Name
Nycomed Investigational Site
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Nycomed Investigational Site
City
Nice
ZIP/Postal Code
6002
Country
France
Facility Name
Nycomed Investigational Site
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Nycomed Investigational Site
City
Strassbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Nycomed Investigational Site
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Nycomed Investigational Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Nycomed Investigational Site
City
Halle
ZIP/Postal Code
6112
Country
Germany
Facility Name
Nycomed Investigational Site
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
Nycomed Investigational Site
City
München
ZIP/Postal Code
81925
Country
Germany
Facility Name
Nycomed Investigational Site
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Nycomed Investigational Site
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
Nycomed Investigational Site
City
Athens
ZIP/Postal Code
15123
Country
Greece
Facility Name
Nycomed Investigational Site
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Facility Name
Nycomed Investigational Site
City
Genova
ZIP/Postal Code
16128
Country
Italy
Facility Name
Nycomed Investigational Site
City
Lecce
ZIP/Postal Code
73100
Country
Italy
Facility Name
Nycomed Investigational Site
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Nycomed Investigational Site
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Nycomed Investigational Site
City
Dammers
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Nycomed Investigational Site
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Facility Name
Nycomed Investigational Site
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Nycomed Investigational Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Nycomed Investigational Site
City
Moscow
ZIP/Postal Code
125047
Country
Russian Federation
Facility Name
Nycomed Investigational Site
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Nycomed Investigational Site
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
Nycomed Investigational Site
City
El Palmar
ZIP/Postal Code
30120
Country
Spain
Facility Name
Nycomed Investigational Site
City
Madrid
ZIP/Postal Code
28049
Country
Spain
Facility Name
Nycomed Investigational Site
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Nycomed Investigational Site
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Nycomed Investigational Site
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Nycomed Investigational Site
City
Göteborg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Nycomed Investigational Site
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Facility Name
Nycomed Investigational Site
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

TASALL - TachoSil® Against Liquor Leak

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