drugset / Trial / NCT02284256
A Safety and Efficacy Study Comparing Fibrocaps and Tachosil in Hepatic Surgery
RandomizedSingle-groupSingle-blindTreatment
Summary
The primary objective of the study is to demonstrate the non-inferiority or superiority of Fibrocaps plus gelatin sponge compared to Tachosil when control of mild to moderate bleeding with conventional surgical techniques is ineffective or impractical.
Timeline
- Start
- 2014-11
- Primary completion
- 2015-08
- Completion
- 2015-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fibrinogen Concentrate Human | Protein / enzyme biologic | — | Topical |
| Comparator | TachoSil | Other / unclassified | — | Topical |
Indications
No indication recorded.