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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Surgicel Original | Other / unclassified | — | Topical |
| Subject | TachoSil | Other / unclassified | — | Topical |