Topical Raplixa for Surgical Bleeding in Children

PHASE2TerminatedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

December 4, 2014

Primary Completion Date

November 17, 2017

Study Completion Date

March 6, 2018

Conditions
Surgical Bleeding
Interventions
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

Trial Locations (13)

19087

SGM Physician Research Consortium, LLC, Wayne

19134

St. Christopher's Hospital for Children, Philadelphia

24013

Carilion Clinic, Roanoke

27157

Wake Forest University School of Medicine, Winston-Salem

30322

Children's Healthcare of Atlanta, Atlanta

32207

Nemours Children's Specialty Care, Jacksonville

60611

Ann and Robert H Lurie Childrens Hospital of Chicago, Chicago

63110

Saint Louis Children's Hospital, St Louis

85008

Arizona Burn Center at Maricopa Medical Center, Phoenix

90027

Children's Hospital Los Angeles, Los Angeles

Children's Medical Center Dallas, Dallas

95817

Shriners Hospital for Children, Sacramento

98105

Seattle Children's Hospital - PIN, Seattle

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mallinckrodt

INDUSTRY

NCT02117349 - Topical Raplixa for Surgical Bleeding in Children | Biotech Hunter | Biotech Hunter