TASALL - TachoSil® Against Liquor Leak

NCT01355627 | Completed Phase 3 Results DMC

• 1 other identifier: TC-2402-038-SP
• Study Type: interventional
• Target: 726
• Locations: 11 countries
• Sites: 39

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.

Conditions

Cerebrospinal Fluid Leaks

Keywords

CSF leaks; Skull base surgery; pseudomeningocele; TachoSil®; Prevention; post-operative

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 8 Weeks (7 Weeks ± 1 Week)

Secondary Outcomes (1)

• Percentage of Participants With Post-Surgical Non-Clinically Evident Post-Operative Pseudomeningocele

  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)

Study Arms (2)

TachoSil®

EXPERIMENTAL

Procedure: TachoSil®

Current practice group

ACTIVE COMPARATOR

Procedure: Current Practice

Interventions

TachoSil® PROCEDURE

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.

TachoSil®

Current Practice PROCEDURE

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®.

Current practice group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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?

Sponsors & Collaborators

• Takeda: lead

Study Sites (39)

Nycomed Investigational Site

Graz, 8036, Austria

Location

Nycomed Investigational Site

Brussels, 1070, Belgium

Location

Nycomed Investigational Site

Genk, 3600, Belgium

Location

Nycomed Investigational Site

Leuven, 3000, Belgium

Location

Nycomed Investigational Site

Liège, 4000, Belgium

Location

Nycomed Investigational Site

Grenoble, 38043, France

Location

Nycomed Investigational Site

Le Kremlin-Bicêtre, 94270, France

Location

Nycomed Investigational Site

Marseille, 13005, France

Location

Nycomed Investigational Site

Nice, 6002, France

Location

Nycomed Investigational Site

Paris, 75010, France

Location

Nycomed Investigational Site

Strasbourg, 67000, France

Location

Nycomed Investigational Site

Toulouse, 31059, France

Location

Nycomed Investigational Site

Freiburg im Breisgau, 79106, Germany

Location

Nycomed Investigational Site

Halle, 6112, Germany

Location

Nycomed Investigational Site

Homburg, 66421, Germany

Location

Nycomed Investigational Site

München, 81925, Germany

Location

Nycomed Investigational Site

Rostock, 18057, Germany

Location

Nycomed Investigational Site

Athens, 10676, Greece

Location

Nycomed Investigational Site

Athens, 15123, Greece

Location

Nycomed Investigational Site

Thessaloniki, 54636, Greece

Location

Nycomed Investigational Site

Genova, 16128, Italy

Location

Nycomed Investigational Site

Lecce, 73100, Italy

Location

Nycomed Investigational Site

Palermo, 90127, Italy

Location

Nycomed Investigational Site

Siena, 53100, Italy

Location

Nycomed Investigational Site

Dammers, 3015 CE, Netherlands

Location

Nycomed Investigational Site

Gdansk, 80-803, Poland

Location

Nycomed Investigational Site

Gdansk, 80-952, Poland

Location

Nycomed Investigational Site

Warsaw, 02-781, Poland

Location

Nycomed Investigational Site

Moscow, 125047, Russia

Location

Nycomed Investigational Site

Barcelona, 8035, Spain

Location

Nycomed Investigational Site

Barcelona, 8036, Spain

Location

Nycomed Investigational Site

El Palmar, 30120, Spain

Location

Nycomed Investigational Site

Madrid, 28049, Spain

Location

Nycomed Investigational Site

Majadahonda, 28222, Spain

Location

Nycomed Investigational Site

Málaga, 29010, Spain

Location

Nycomed Investigational Site

Santiago de Compostela, 15706, Spain

Location

Nycomed Investigational Site

Gothenburg, 41345, Sweden

Location

Nycomed Investigational Site

Lund, 22185, Sweden

Location

Nycomed Investigational Site

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Cerebrospinal Fluid Leak

Interventions

TachoSil

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Results Point of Contact

• Title: Medical Director, Clinical Science
• Organization: Takeda

clinicaltrialregistry@tpna.com

800-778-2860

Study Officials

• Nycomed

  Clinical Trial Operations

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2011
• First Posted: May 18, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 25, 2014
• Results First Posted: July 25, 2014

Record last verified: 2014-06

Locations

RU (1); AU (1); BE (4); PL (3); DE (5); NL (1); FR (7); IT (4); ES (7); GR (3); SE (3)