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NCT01495637 · ClinicalTrials.gov registry record · Phase 4
GM-CSF for Immunomodulation Following Trauma (GIFT) Study
A Phase 4 study of Critical Injury (Trauma) in Children, sponsored by Mark Hall.
- Completed
- Registry status
- Phase 4
- Development phase
- 108
- Enrollment target
- 8
- Study locations
NCT01495637: Completed Phase 4 study of Critical Injury (Trauma) in Children, sponsored by Mark Hall.
NCT01495637 is a Phase 4 study of Critical Injury (Trauma) in Children that has completed, run by Mark Hall. The registered enrollment target is 108 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01495637, a Phase 4 study of Critical Injury (Trauma) in Children, has completed, sponsored by Mark Hall.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 108 participants
- Enrollment target
- 8
- Study locations
Study 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 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.
Primary Outcome
To identify the lowest immunostimulatory yet tolerable dose of GM-CSF that produces lasting improvement in innate immune function in treated children.
Conditions Studied
Interventions
- DRUG GM-CSF
Study Locations (8)
Ohio
- Cincinnati Children's Medical Center - Cincinnati
- Nationwide Children's Hospital - Columbus
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
- Children's Hospital of Pittsburgh - Pittsburgh
Colorado
- Children's Hospital of Colorado - Aurora
District of Columbia
- Children's National Medical Center - Washington D.C.
Michigan
- Children's Hospital of Michigan - Detroit
Missouri
- Washington University / St. Louis Children's Hospital - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2011-12 |
| Est. Completion | 2023-02 |
| Phase | Phase 4 |
What the finished NCT01495637 record still lists
NCT01495637 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Critical Injury (Trauma) in Children appearing as the primary indexed condition, and to 1 intervention - of which GM-CSF is the first listed.
NCT01495637 lists 8 locations in 6 states (Ohio, Pennsylvania, Colorado).
Frequently Asked Questions
What is clinical trial NCT01495637 about?
NCT01495637 is a clinical study titled "GM-CSF for Immunomodulation Following Trauma (GIFT) Study". 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...
What is the current status of trial NCT01495637?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 108 participants. The study started on 2011-12. Estimated completion is 2023-02.
What conditions does trial NCT01495637 study?
This clinical trial studies the following conditions: Critical Injury (Trauma) in Children.
What interventions are being tested in trial NCT01495637?
The interventions under investigation include: GM-CSF (DRUG).
Who is sponsoring clinical trial NCT01495637?
This trial is sponsored by Mark Hall, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01495637 being conducted?
This trial has 8 study locations across Colorado, District of Columbia, Michigan, Missouri, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01495637's enrollment target sits among peer trials
108 740th of 2000 higher than 1,257 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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