drugset / Trial / NCT01192022

TachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery

NCT01192022

Phase 3 Completed 253 enrolled Takeda
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2010-08
Primary completion
2013-05
Completion
2013-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator TachoSil Other / unclassified Topical

Indications