55
Participants
Start Date
December 4, 2014
Primary Completion Date
November 17, 2017
Study Completion Date
March 6, 2018
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.
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.
Rescue treatment
Thrombin-containing hemostats included in standard care at the site
SGM Physician Research Consortium, LLC, Wayne
St. Christopher's Hospital for Children, Philadelphia
Carilion Clinic, Roanoke
Wake Forest University School of Medicine, Winston-Salem
Children's Healthcare of Atlanta, Atlanta
Nemours Children's Specialty Care, Jacksonville
Ann and Robert H Lurie Childrens Hospital of Chicago, Chicago
Saint Louis Children's Hospital, St Louis
Arizona Burn Center at Maricopa Medical Center, Phoenix
Children's Hospital Los Angeles, Los Angeles
Children's Medical Center Dallas, Dallas
Shriners Hospital for Children, Sacramento
Seattle Children's Hospital - PIN, Seattle
Lead Sponsor
Mallinckrodt
INDUSTRY