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

NCT01192022 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Takeda
Phase	Phase 3
Status	COMPLETED
Enrolment	253
Start date	2010-08
Completion	2013-05

Conditions

• Hemorrhage

Interventions

• TachoSil®
• Surgicel® Original

Primary outcomes

• Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes — within 3 minutes
  3 Minutes after the patch was applied to the target bleeding area, the area was observed to see if the bleeding stopped.

Countries

United States