Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TachoSil, Current Practice · 1 trial · 1 indication
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...
TachoSil is used for Cerebrospinal Fluid Leaks, Bleeding, and Hemorrhage. It is an investigational small molecule being developed by Takeda Pharmaceutical Company Limited (TAK) for these indications in the therapeutic area of Hematology.
TachoSil is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The drug is currently in Phase 3 clinical development for Cerebrospinal Fluid Leaks, Bleeding, and Hemorrhage.
TachoSil is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Three Phase 3 trials have been completed, with a total enrollment of 726 patients across studies.
TachoSil has completed three Phase 3 trials: NCT01192022 for Hemorrhage in hepatic resection, NCT01355627 for Cerebrospinal Fluid Leaks, and NCT01500135 for Bleeding in vascular surgery. All trials are completed, with no active trials currently ongoing.
TachoSil is not the same as Surgicel. In clinical trials, TachoSil was compared against Surgicel Original as an active control for secondary treatment of local bleeding and needle hole bleeding. TachoSil is the investigational product being studied.