drugset / Trial / NCT01500135

Comparison of Efficacy and Safety of TachoSil® Versus Surgicel® Original for the Secondary Hemostatic Treatment of Needle Hole Bleeding in Vascular Surgery

NCT01500135

Phase 3 Completed 150 enrolled Takeda Baxter Healthcare Corporation · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

Present trial is the third study that in combination with two completed studies (one being a trial in hepatic resection surgery also comparing TachoSil® and Surgicel® Original) targeted toward providing clinical safety and efficacy data to support extending the current label of TachoSil® to a general hemostasis indication across several surgical procedures and organ systems in the USA.

Timeline

Start
2012-03
Primary completion
2015-06
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Surgicel Original Other / unclassified Topical
Subject TachoSil Other / unclassified Topical

Indications