Clinical Trial: TASALL - TachoSil® Against Liquor Leak

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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, Randomi

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 Summary:
Sponsor: Takeda

Current 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.


Original Primary Outcome: To evaluate the occurrence of a clinically evident cerebrospinal fluid leak or clinically evident pseudomeningocele [ Time Frame: Up to 7 weeks ]

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


Current 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) ]

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.


Original Secondary Outcome: To evaluate the occurrence of non-clinical evident pseudomeningocele [ Time Frame: The participants will be assessed at least once from day of surgery until discharge from neurosurgical ward, with the expected discharge from neurosurgical ward after an average of 10 days ]

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


Information By: Takeda

Dates:
Date Received: May 11, 2011
Date Started: April 2011
Date Completion:
Last Updated: June 26, 2014
Last Verified: June 2014