TASALL - TachoSil® Against Liquor Leak

Phase 3

Completed

• Conditions: Cerebrospinal Fluid Leaks
• Interventions: Procedure: TachoSil®; Procedure: Current Practice

• Registration Number: NCT01355627
• Lead Sponsor: Takeda

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-05-11
• Study First Submitted QC: 2011-05-17
• Study First Posted: 2011-05-18
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-06
• Results First Submitted: 2014-06-26
• Results First Submitted QC: 2014-06-26
• Last Update Submitted: 2014-06-26
• Results First Posted: 2014-07-25
• Last Update Posted: 2014-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 726

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TachoSil®	TachoSil®	-
Current practice group	Current Practice	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)	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.

Trial Locations

Locations (1)

Nycomed Investigational Site; 🇸🇪 Stockholm, Sweden