Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

GM-CSF for Immunomodulation Following Trauma (GIFT) Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Nationwide Children's Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mark Hall, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01495637
First received: December 13, 2011
Last updated: July 18, 2014
Last verified: July 2014

December 13, 2011
July 18, 2014
December 2011
June 2016   (final data collection date for primary outcome measure)
Nosocomial infection [ Time Frame: 14-days post-trauma ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01495637 on ClinicalTrials.gov Archive Site
  • Innate immune function [ Time Frame: Day 4 post-trauma ] [ Designated as safety issue: No ]
    To identify the lowest immunostimulatory yet tolerable dose of GM-CSF that produces lasting improvement in innate immune function in treated children.
  • Nosocomial infection [ Time Frame: 28-days post-trauma ] [ Designated as safety issue: Yes ]
  • Innate Immune Function [ Time Frame: Day 14 post-trauma ] [ Designated as safety issue: No ]
    To identify the lowest immunostimulatory yet tolerable dose of GM-CSF that produces lasting improvement in innate immune function in treated children.
Same as current
Not Provided
Not Provided
 
GM-CSF for Immunomodulation Following Trauma (GIFT) Study
GM-CSF for Immunomodulation Following Trauma (GIFT) Study

The GIFT study is an interventional trial using the drug GM-CSF for the reversal of innate immune suppression in critically injured children. The study will be conducted in two phases, a dose-finding phase then an efficacy phase. The central hypothesis of the study is that immunomodulation with GM-CSF will result in reduction in the risk of nosocomial infection after critical injury in high-risk children through safe, rapid, and sustained improvement in innate immune function.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Critical Injury (Trauma) in Children
  • Drug: GM-CSF
    GM-CSF is to be administered IV on post-trauma days 1, 2, and 3 at a dose of 30, 62, or 125 mcg/m2 per day.
    Other Names:
    • sargramostim
    • leukine
  • Drug: placebo
    placebo will be administered on post-trauma days 1, 2, and 3
  • Active Comparator: GM-CSF
    Intervention: Drug: GM-CSF
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
June 2016
June 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Admission to the PICU at Nationwide Children's Hospital or SICU at the Ohio State University Wexner Medical Center (OSUWMC).
  • A primary diagnosis of blunt or penetrating trauma that occurred within the last 24 hours
  • Age 1 - 21 years
  • Injury Severity Score (ISS) > 10
  • Presence of an endotracheal tube at the time of enrollment

Exclusion Criteria:

  • Presence of limitations of care such as "Do not intubate" or "Do not resuscitate" orders
  • Fixed, dilated pupils in the Emergency Department at NCH; Glasgow Coma Scale score of 3 (in the absence of neuromuscular blocking drugs) in the Emergency Department at NCH; or presence of a new, severe neurologic injury at the time of enrollment which, in the opinion of the treating physician, is highly likely to lead to a diagnosis of brain death
  • Cardiopulmonary arrest requiring CPR documented by EMS or hospital personnel prior to subject identification
  • Burn injury of any kind (scald, fire, chemical)
  • Children receiving acute or chronic immunosuppressive therapy (e.g. systemic corticosteroids, calcineurin inhibitors, mycophenolate, azathioprine) at the time of injury
  • Children with severe leukopenia (white blood cell count < 1000 cells/mm3) at the time of injury as the result of myeloablative chemotherapy or radiation
  • Pregnancy
  • Autoimmune thrombocytopenia, myelodysplastic syndromes with > 20% marrow blast cells, or known allergy/hypersensitivity to GM-CSF (all contra-indications to receiving GM-CSF)
Both
1 Year to 21 Years
No
Contact: Mark W Hall, MD 614-722-3438 Mark.Hall@NationwideChildrens.org
United States
 
NCT01495637
GIFT Study, R01GM094203-01A1
Yes
Mark Hall, Nationwide Children's Hospital
Mark Hall
National Institute of General Medical Sciences (NIGMS)
Principal Investigator: Mark W Hall, MD Nationwide Children's Hospital
Nationwide Children's Hospital
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP