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TachoSil · 3 trials · 3 indications
After application of Investigational Medicinal Product (IMP) light pressure was applied to the IMP with e.g. gauze pads. The first assessment of hemostasis was at minute 3: the pressure was carefully relieved, and the area was observed for visual bleeding at the site of the IMP. If no bleeding was visible, hemostasis was obtained and recorded.
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.
3 Minutes after the patch was applied to the target bleeding area, the area was observed to see if the bleeding stopped.
| Arm | Type | Description |
|---|---|---|
| TachoSil® | EXPERIMENTAL | TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated. |
| Surgicel® Original | ACTIVE_COMPARATOR | Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated. |
| Current practice group | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| TachoSil® | DRUG | TachoSil® is a sterile, ready-to-use, absorbable patch for intra-operative topical application. It consists of an equine collagen patch coated with fibrin glue components: human fibrinogen and human thrombin. |
| Surgicel® Original | DRUG | Surgicel® Original is an absorbable hemostat (oxidized regenerated cellulose) |
| 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: * Planned elective and subacute procedures with a polytetrafluoroethylene (PTFE) graft including at least one expected end-to-side anastomosis of a PTFE graft to the femoral artery (e.g. femoral-femoral cross-over, aorto-(bi)femoral, axillo-(bi)femoral, femoro-popliteal, fe...
TachoSil is used for hemostatic and sealing support in surgical settings, including controlling bleeding during vascular and hepatic resection surgery and managing cerebrospinal fluid leaks. Its Phase 3 clinical program evaluated these uses in adult and pediatric patients. The product is developed by Takeda Pharmaceutical Company Limited.
TachoSil is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical trials evaluating TachoSil in bleeding, cerebrospinal fluid leaks, and hemorrhage.
TachoSil has been evaluated in Phase 3 clinical trials. Three completed Phase 3 studies are registered, including NCT01500135, NCT01355627, and NCT01192022. These trials assessed TachoSil in bleeding, cerebrospinal fluid leaks, and hemorrhage.
TachoSil has been studied in three completed Phase 3 trials: NCT01500135 compared TachoSil to Surgicel Original for needle hole bleeding in vascular surgery; NCT01355627 (TASALL) evaluated TachoSil for cerebrospinal fluid leaks; and NCT01192022 compared TachoSil to Surgicel Original for local bleeding in hepatic resection surgery.
Yes, TachoSil and TachoSil® refer to the same product. The registered trademark symbol is often included in formal documentation, but both names denote the same hemostatic agent developed by Takeda Pharmaceutical Company Limited.