NCT01355627

TASALL - TachoSil® Against Liquor Leak

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 726 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	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	Current Practice	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®.

Timeline

• Start date: 2011-04-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2011-05-18
• Last updated: 2014-07-25
• Results posted: 2014-07-25

Locations

39 sites across 11 countries: Austria, Belgium, France, Germany, Greece, Italy, Netherlands, Poland, Russia, Spain, Sweden