Status:
COMPLETED
GM-CSF for Immunomodulation Following Trauma (GIFT) Study
Lead Sponsor:
Mark Hall
Collaborating Sponsors:
National Institute of General Medical Sciences (NIGMS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Critical Injury (Trauma) in Children
Eligibility:
All Genders
1-17 years
Phase:
PHASE4
Brief Summary
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 t...
Detailed Description
The current phase of the study is an open-label dose-finding phase in which critically injured children undergo prospective, serial immune function testing in the first few days after injury. If a sub...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT01495637
Start Date
December 1 2011
End Date
February 1 2023
Last Update
September 13 2023
Active Locations (8)
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1
Children's Hospital of Colorado
Aurora, Colorado, United States, 80045
2
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
3
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
4
Washington University / St. Louis Children's Hospital
St Louis, Missouri, United States, 63110