drugset / Trial / NCT02117349
Topical Raplixa for Surgical Bleeding in Children
RandomizedParallel-groupSingle-blindTreatment
Summary
The purpose of the study is to determine if Raplixa plus Gelfoam is better than Gelfoam alone in stopping mild to moderate bleeding in children having surgery.
Timeline
- Start
- 2014-12-04
- Primary completion
- 2017-11-17
- Completion
- 2018-03-06
Outcome
Met primary endpoint
Stopped: “Non-safety device related issues”
registry analysis (other test); Raplixa Plus Gelfoam vs Gelfoam Alone; p = 0.0010; Odds Ratio (OR) 42.8 (95% CI 4.58 to 401.0) NCT02117349 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fibrinogen Concentrate Human | Protein / enzyme biologic | 2 g | Topical |
Indications
No indication recorded.