Trials / Completed
CompletedNCT01527357
A Study of Fibrocaps™ in Surgical Bleeding
A Phase 3, Randomized, Single-blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Hemostasis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 721 (actual)
- Sponsor
- Mallinckrodt · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to confirm the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis. The investigational products were used in participants with mild to moderate surgical bleeding during spine, liver, vascular or soft tissue surgery, when control of mild to moderate bleeding by standard surgical techniques is ineffective and/or impractical.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Fibrocaps | Human fibrinogen and thrombin powder, for topical administration. |
| BIOLOGICAL | Gelatin sponge | Absorbable gelatin sponge for topical administration. |
Timeline
- Start date
- 2012-05-21
- Primary completion
- 2013-04-24
- Completion
- 2013-06-01
- First posted
- 2012-02-07
- Last updated
- 2019-12-18
- Results posted
- 2019-12-18
Locations
48 sites across 4 countries: United States, Belgium, Netherlands, United Kingdom
Source: ClinicalTrials.gov record NCT01527357. Inclusion in this directory is not an endorsement.