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
  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 Study Completion Date: June 2016
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 18, 2014
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 October 19, 2014