Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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. The trial reports 8 study locations across 6 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01495637
The ClinicalTrials.gov registry entry for NCT01495637 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mark Hall, which has 1 total studies on file at ClinicalTrials.gov.
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 reports 8 study locations spanning 6 distinct geographic areas - top geographies include 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
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.