Trials / Completed
CompletedNCT02284256
A Safety and Efficacy Study Comparing Fibrocaps and Tachosil in Hepatic Surgery
A Phase 3b, Randomized, Single-Blind, Controlled, Comparative Efficacy and Safety Study of Topical FibrocapsTM (RaplixaTM) and Tachosil® in Surgical Hemostasis During Hepatic Resection
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 150 (actual)
- Sponsor
- Mallinckrodt · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fibrocaps | |
| DRUG | TachoSil |
Timeline
- Start date
- 2014-11-01
- Primary completion
- 2015-08-01
- Completion
- 2015-08-01
- First posted
- 2014-11-05
- Last updated
- 2017-08-16
Locations
15 sites across 2 countries: Austria, Germany
Source: ClinicalTrials.gov record NCT02284256. Inclusion in this directory is not an endorsement.