GM-CSF for Immunomodulation Following Trauma (GIFT) Study

This study is currently recruiting participants.
Verified September 2013 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: September 3, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Critical Injury (Trauma) in Children
Drug: GM-CSF
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: GM-CSF for Immunomodulation Following Trauma (GIFT) Study

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Nosocomial infection [ Time Frame: 14-days post-trauma ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 200
Study Start Date: December 2011
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: GM-CSF 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
Placebo Comparator: placebo Drug: placebo
placebo will be administered on post-trauma days 1, 2, and 3

  Eligibility

Ages Eligible for Study:   1 Year to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01495637

Contacts
Contact: Mark W Hall, MD 614-722-3438 Mark.Hall@NationwideChildrens.org

Locations
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Mark W Hall, MD    614-722-3438    Mark.Hall@NationwideChildrens.org   
Sponsors and Collaborators
Mark Hall
Investigators
Principal Investigator: Mark W Hall, MD Nationwide Children's Hospital
  More Information

No publications provided

Responsible Party: Mark Hall, Assistant Professor of Pediatrics, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01495637     History of Changes
Other Study ID Numbers: GIFT Study, R01GM094203-01A1
Study First Received: December 13, 2011
Last Updated: September 3, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Nationwide Children's Hospital:
pediatric
trauma
critical
GM-CSF
immune

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on April 22, 2014