Topical Raplixa for Surgical Bleeding in Children

Stopped early · Phase 2

Conditions studied: Surgical Bleeding

In brief

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.

Key facts

Study ID

NCT02117349

Run by

Mallinckrodt

People needed

55

Starts

2014-12-04

Expected to finish

2018-03-06

Last updated by the study team

2020-02-05

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Has any clinically significant laboratory or vital sign value, chronic disease state, or congenital coagulation disorder (eg, hemophilia A or B) that the investigator determines could interfere with the assessment of efficacy or pose a safety risk to the participant
• Is unwilling to receive blood products
• Has known antibodies or hypersensitivity to porcine gelatine, Raplixa or any of it's components, or other thrombin preparations or coagulation factors
• Has medical, social, or psychosocial factors that, in the opinion of the Investigator, could impact safety of the participant or compliance with study procedures, including protocol-defined limits on participating in other clinical studies

Where it is running

• Arizona Burn Center at Maricopa Medical Center — Phoenix, Arizona, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Shriners Hospital for Children — Sacramento, California, United States
• Nemours Children's Specialty Care — Jacksonville, Florida, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Ann and Robert H Lurie Childrens Hospital of Chicago — Chicago, Illinois, United States
• Saint Louis Children's Hospital — St Louis, Missouri, United States
• Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States
• St. Christopher's Hospital for Children — Philadelphia, Pennsylvania, United States
• SGM Physician Research Consortium, LLC — Wayne, Pennsylvania, United States
• Children's Medical Center Dallas — Dallas, Texas, United States
• Carilion Clinic — Roanoke, Virginia, United States
• Seattle Children's Hospital - PIN — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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