GM-CSF for Immunomodulation Following Trauma (GIFT) Study

Completed · Phase 4

Conditions studied: Critical Injury (Trauma) in Children

In brief

The GIFT study is a prospective, multi-center, 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 dose-finding phase is the current active phase of the study. 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.

Key facts

Study ID

NCT01495637

Run by

Mark Hall

People needed

108

Starts

2011-12-01

Expected to finish

2023-02-01

Last updated by the study team

2023-09-13

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Admission to the PICU at a GIFT study site with a primary diagnosis of blunt or penetrating trauma that occurred within the last 72 hours.
• Age 1 - 17 years
• Provisional Injury Severity Score (ISS) > 10
• Presence of an endotracheal tube at the time of enrollment

You may not qualify if…

• DNR status or care team/family is considering plans for withdrawal of life-sustaining therapies.
• Strong suspicion of injuries related to child abuse, in the opinion of the treating physician
• Persistence (after treatment) of any of the following in the PICU before enrollment: Fixed, dilated pupils; Glasgow Coma Scale score of 3 (in the absence of neuromuscular blocking drugs); 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)
• Patients receiving acute or chronic immunosuppressive therapy (e.g., systemic corticosteroids, calcineurin inhibitors, mycophenolate, azathioprine) at the time of injury
• Patients 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
• Previously enrolled in the GIFT study

Where it is running

• Children's Hospital of Colorado — Aurora, Colorado, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• Washington University / St. Louis Children's Hospital — St Louis, Missouri, United States
• Cincinnati Children's Medical Center — Cincinnati, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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