GM-CSF for Immunomodulation Following Trauma (GIFT) Study

PHASE4CompletedINTERVENTIONAL
Enrollment

108

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

February 28, 2022

Study Completion Date

February 28, 2023

Conditions
Critical Injury (Trauma) in Children
Interventions
DRUG

GM-CSF

GM-CSF is to be administered IV at one of four possible dosing regimens (three days at a dose of 30, 62, or 125 mcg/m2 per day, or an extended dosing regimen of 125 mcg/m2/day through post-trauma 6) if severe innate immune suppression is identified on post-trauma days 1, 2, or 3.

Trial Locations (8)

15224

Children's Hospital of Pittsburgh, Pittsburgh

19104

Children's Hospital of Philadelphia, Philadelphia

20010

Children's National Medical Center, Washington D.C.

43205

Nationwide Children's Hospital, Columbus

45229

Cincinnati Children's Medical Center, Cincinnati

48201

Children's Hospital of Michigan, Detroit

63110

Washington University / St. Louis Children's Hospital, St Louis

80045

Children's Hospital of Colorado, Aurora

All Listed Sponsors
collaborator

National Institute of General Medical Sciences (NIGMS)

NIH

collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

Mark Hall

OTHER

NCT01495637 - GM-CSF for Immunomodulation Following Trauma (GIFT) Study | Biotech Hunter | Biotech Hunter