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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
55
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.
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.
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
Number of Participants Who Reached Hemostasis at the Target Bleeding Site (TBS) Within 4 Minutes
Count of Participants who Reached Hemostasis at the TBS within 4 minutes of the first study drug application
Time frame: within 4 minutes
Number of Participants Who Reached Hemostasis at the TBS Within 5 Minutes
Count of Participants who Reached Hemostasis at the TBS within 5 minutes of the first study drug application
Time frame: within 5 minutes
Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs)
Clinically significant changes in safety measures are recorded as adverse events. Participants with TEAEs that are deemed by the principal investigator or the independent data monitoring committee as possibly or definitely treatment-related (including device-related) are included in the count for this secondary outcome measure.
Time frame: within 97 days
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Thrombin-containing hemostats included in standard care at the site
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
...and 3 more locations