Trials / Terminated
TerminatedNCT02117349
Topical Raplixa for Surgical Bleeding in Children
A Phase 2, Randomized, Single-Blind, Controlled Trial of Topical Raplixa™ (Fibrin Sealant [Human]) in Intraoperative Surgical Hemostasis in a Pediatric Population
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- Mallinckrodt · Industry
- Sex
- All
- Age
- 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Raplixa | Raplixa is a biological product approved for use in adults to help control bleeding from small blood vessels when standard surgical techniques, such as suture, ligature or cautery, are ineffective or impractical. When applied to a bleeding site, Raplixa is dissolved in the blood and a reaction starts between the fibrinogen and thrombin proteins. This results in the formation of blood clots to help stop the bleeding. |
| DEVICE | Gelfoam | Gelfoam Sterile Sponge is a medical device (USP, Pfizer) intended for application to bleeding surfaces as a hemostatic. It is a water-insoluble, off-white, nonelastic, porous, pliable product. It may be cut without fraying, used wet or dry, and is able to absorb many times its weight in blood and other fluids. |
| DRUG | Rescue treatment | Thrombin-containing hemostats included in standard care at the site |
Timeline
- Start date
- 2014-12-04
- Primary completion
- 2017-11-17
- Completion
- 2018-03-06
- First posted
- 2014-04-17
- Last updated
- 2020-02-05
- Results posted
- 2020-02-05
Locations
13 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02117349. Inclusion in this directory is not an endorsement.