blood sampling / Trauma Injury / Sepsis · Observational Study

Dysfunctional Myelopoiesis and Myeloid-Derived Suppressor Cells in Sepsis

ClinicalTrials.gov · August 19, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned observational study registered at ClinicalTrials.gov investigating myelopoiesis dysfunction and myeloid-derived suppressor cell expansion in sepsis and trauma patients through serial blood sampling. No results are currently reported in this registry record, and the study is actively recruiting.

What was studied

Observational. Sepsis, Trauma Injury; age from 18 Years; to 100 Years; accepts healthy volunteers. Intervention: Sepsis; Healthy Controls; Trauma. n = 450. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is an active observational registry record with no reported results; it describes a planned mechanistic study of immune cell populations in sepsis without outcome data or effect estimates.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measure: The total number of neutrophils and early myeloid derived suppressor cells will be measured and will be used to determine the magnitude of myelopoiesis dysfunction. (assessed at 6 months)

DesignObservational

PopulationSepsis, Trauma Injury; age from 18 Years; to 100 Years; accepts healthy volunteers

Sample size450

InterventionSepsis; Healthy Controls; Trauma

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment450

Primary outcome measureTotal number of neutrophils and early myeloid-derived suppressor cells; measured to determine magnitude of myelopoiesis dysfunction

Follow-up duration6 months

Caveats

This is a registry record with no results reported; no outcome data, effect sizes, or clinical findings are available.
Study methods, randomization procedures, blinding, and statistical analysis plan are not described in this registry excerpt.
Primary outcomes are mechanistic (cell counts) rather than clinical endpoints; clinical significance is unknown.
Recruitment status is active; study completion date and data availability are not specified.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Observational design with blood sampling; no randomization or control arm stated.

Directness

limited

Primary outcomes are mechanistic cell counts, not clinical endpoints or patient-relevant outcomes.

Consistency

insufficient

No results reported; consistency with other evidence cannot be assessed from registry record alone.

Risk of bias

insufficient

Study methods, blinding, and analytical approach not described in registry record.

Sample adequacy

moderate

Estimated enrollment 450 participants; adequacy depends on effect sizes and variance not yet reported.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT05110937). This is a study registration, not published results. Lead sponsor: University of Florida. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 450 participants (ESTIMATED). Conditions: Sepsis, Trauma Injury. Interventions: OTHER: Blood sampling. Primary outcome measures: The total number of neutrophils and early myeloid derived suppressor cells will be measured and will be used to determine the magnitude of myelopoiesis dysfunction. , 6 months. Brief summary: Adverse outcomes in surgical sepsis patients are secondary to dysregulated emergency myelopoiesis, and expansion of myeloid-derived suppressor cells. Here we propose to determine the underlying mechanisms behind the increased expansion of these leukocyte populations and the underlying mechanisms that drive inflammation and immune suppression.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

University of FloridaNCT05110937blood samplingTrauma InjurySepsis