Cerebrospinal Fluid LeaksPhase 3NCT01355627
TASALL - TachoSil® Against Liquor Leak
A Phase 3 study testing TachoSil® and Current Practice in people with Cerebrospinal Fluid Leaks, run by Takeda at 39 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrospinal Fluid Leaks
- What is being tested?
- TachoSil® and Current Practice
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 726 participants
- Where
- 39 sitesin 11 countries
- Study dates
- Apr 2011to Jun 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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?
Trial locations and contacts
39 sites in 11 countries.
39 sites in 11 countries
France7 sites
Nycomed Investigational Site
Grenoble, 38043
Nycomed Investigational Site
Le Kremlin-Bicêtre, 94270
Nycomed Investigational Site
Marseille, 13005
Nycomed Investigational Site
Nice, 6002
Nycomed Investigational Site
Paris, 75010
Nycomed Investigational Site
Strasbourg, 67000
Nycomed Investigational Site
Toulouse, 31059
Spain7 sites
Nycomed Investigational Site
Barcelona, 8035
Nycomed Investigational Site
Barcelona, 8036
Nycomed Investigational Site
El Palmar, 30120
Nycomed Investigational Site
Madrid, 28049
Nycomed Investigational Site
Majadahonda, 28222
Nycomed Investigational Site
Málaga, 29010
Nycomed Investigational Site
Santiago de Compostela, 15706
Germany5 sites
Nycomed Investigational Site
Freiburg im Breisgau, 79106
Nycomed Investigational Site
Halle, 6112
Nycomed Investigational Site
Homburg, 66421
Nycomed Investigational Site
München, 81925
Nycomed Investigational Site
Rostock, 18057
Belgium4 sites
Nycomed Investigational Site
Brussels, 1070
Nycomed Investigational Site
Genk, 3600
Nycomed Investigational Site
Leuven, 3000
Nycomed Investigational Site
Liège, 4000
Italy4 sites
Nycomed Investigational Site
Genova, 16128
Nycomed Investigational Site
Lecce, 73100
Nycomed Investigational Site
Palermo, 90127
Nycomed Investigational Site
Siena, 53100
Greece3 sites
Nycomed Investigational Site
Athens, 10676
Nycomed Investigational Site
Athens, 15123
Nycomed Investigational Site
Thessaloniki, 54636
Poland3 sites
Nycomed Investigational Site
Gdansk, 80-803
Nycomed Investigational Site
Gdansk, 80-952
Nycomed Investigational Site
Warsaw, 02-781
Sweden3 sites
Nycomed Investigational Site
Gothenburg, 41345
Nycomed Investigational Site
Lund, 22185
Nycomed Investigational Site
Stockholm, 17176
About this study
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.
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.
- Conditions
- Cerebrospinal Fluid Leaks
- Being tested
- TachoSil®, Current Practice
- Keywords
- CSF leaks, Skull base surgery, pseudomeningocele, TachoSil®, Prevention, post-operative
- Medical subject headings
- Cerebrospinal Fluid Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TachoSil®Procedure or surgery
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.
Current PracticeProcedure or surgery
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®.
| Study group | Role | What they receive |
|---|---|---|
| TachoSil® | Experimental | Not described Receives: Procedure: TachoSil® |
| Current practice group | Active comparator | Not described Receives: Procedure: Current Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 8 Weeks (7 Weeks ± 1 Week)
Secondary outcomes (1)
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cerebrospinal Fluid LeaksStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 726 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nycomed, Study chair, Clinical Trial Operations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01355627
- Sponsor's protocol ID
- TC-2402-038-SP
- Status last verified
- Jun 2014
- First submitted
- 11 May 2011
- Last updated
- 25 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01355627
- Acronym / sponsor ID
- TC-2402-038-SP
- Conditions
- Cerebrospinal Fluid Leaks
- Keywords
- CSF leaks, Skull base surgery, pseudomeningocele, TachoSil®, Prevention, post-operative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 726 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 18 May 2011 (estimated)
- Results
- Posted 25 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TachoSil® | Experimental | Procedure: TachoSil® |
| Current practice group | Active comparator | Procedure: Current Practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | TachoSil® |
| Current PracticePrimary 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®. | Procedure or surgery | Current practice group |
Primary outcome
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)
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.
1 secondary outcome
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nycomed study chair
Clinical Trial Operations
39 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TachoSil® and Current Practice in people with Cerebrospinal Fluid Leaks, run by Takeda at 39 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in France, Spain, Germany, Belgium, Italy and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2014.