GM-CSF for Immunomodulation Following Trauma (GIFT) Study
(GIFT Trial)

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen byMark W Hall, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Mark Hall

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Mark W Hall, MD

Principal Investigator

Nationwide Children's Hospital

Eligibility Criteria

Inclusion Criteria

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

See 1 more

Treatment Details

Interventions

GM-CSF (Cytokine)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: GM-CSFExperimental Treatment1 Intervention

GM-CSF is given in one of four treatment regimens (three days at a dose of 30, 62, or 125 mcg/m2/day, or extended dosing at 125 mcg/m2 through post-trauma day 6) to critically injured children who demonstrate severe reduction in innate immune function on post-trauma day 1, 2, or 3.

GM-CSF is already approved in Canada for the following indications: