Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01355627 | TASALL - TachoSil® Against Liquor Leak | PHASE3 | COMPLETED | 726 | — | — | Apr 1, 2011 | Jun 1, 2013 | Jul 25, 2014 | 39 | Austria, Belgium +9 |
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.
| Arm | Type | Description |
|---|---|---|
| TachoSil® | EXPERIMENTAL | - |
| Current practice group | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| 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. |
| 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®. |
Main Inclusion Criteria (Positive response): • 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, j...