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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01192022 | TachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery | PHASE3 | COMPLETED | 253 | — | — | Aug 1, 2010 | May 1, 2013 | Nov 25, 2015 | 17 | United States |
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® | ACTIVE_COMPARATOR | TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. 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 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® | BIOLOGICAL | Intraoperative application as secondary hemostatic treatment |
| Surgicel® Original | DEVICE | Intraoperative application as secondary hemostatic treatment |
Inclusion Criteria: * Resection of at least the equivalent tissue volume of 1 anatomical segment of the liver * Minor to moderate (oozing/diffuse) bleeding from the resection area persisting after conventional resection procedure and primary control of arterial pulsating bleeding or major venous he...