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TachoSil · 2 trials · 2 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.
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. |
| 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) |
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 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.