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) ]
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
- Glucose concentration test and/or
- β-2-transferrin test
A clinically evident pseudomeningocele must be considered to be present post-operatively if the following criteria are fulfilled
- A subcutaneous, visible/palpable fluctuant fluid accumulation is noted at the site of the surgical incision or adjacent to it
- 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) ]
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