Trials / Completed
CompletedNCT01192022
TachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery
A Randomized, Open Label, Parallel-group, Multi-center Trial to Compare the Efficacy and Safety of TachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 253 (actual)
- Sponsor
- Takeda · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The efficacy and safety of TachoSil® as secondary hemostatic treatment in hepatic resection surgery will be compared to the standard USA licensed hemostatic agent, Surgicel® Original. Hemostatic efficacy will be evaluated intraoperatively after application of randomized treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | TachoSil® | Intraoperative application as secondary hemostatic treatment |
| DEVICE | Surgicel® Original | Intraoperative application as secondary hemostatic treatment |
Timeline
- Start date
- 2010-08-01
- Primary completion
- 2013-05-01
- Completion
- 2013-05-01
- First posted
- 2010-08-31
- Last updated
- 2015-11-25
- Results posted
- 2015-11-25
Locations
17 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01192022. Inclusion in this directory is not an endorsement.