NCT06606119 · University of Florida
The Role of Brain-Bone Marrow-Gut Interaction Following Major Trauma
What this study is about
Traumatic injury followed by critical illness provokes pathophysiologic changes in the bone marrow and the gut that contribute to persistent anemia and changes in the microbiome which significantly impact long-term recovery.
View original scientific description
Traumatic injury followed by critical illness provokes pathophysiologic changes in the bone marrow and the gut that contribute to persistent anemia and changes in the microbiome which significantly impact long-term recovery. This project will define the interactions between the stress, chronic inflammation, bone marrow dysfunction, and an altered microbiome which will provide a strong foundation for future clinical interventions to help improve outcomes following severe trauma.
Interventions
OTHER
Data and tissue collection
Collection of bone marrow, blood, feces, medical record data, and patient response surveys.
Primary outcome measures
Link the changes in HSPC and erythroid progenitor cell fate and function with sympathetic stress-induced changes establishing brain-bone marrow communication following trauma.
Time frame: 3 years
The impact of the severity and duration of catecholamine secretion on the cellular biology of HSPCs and erythroid progenitor cells requires further detailed evaluation. At each stage of proliferation and differentiation, there is a complex interaction of cytokines, transcription factors, post-translational modification of histones, and miRs. Single-cell RNA-seq technologies using a novel second generation multi-omics technology, CITE-seq, will be used for identification of isolated HSPCs and erythroid progenitor cells. Such single cell sequencing technology is ideal for cell populations with a great deal of heterogeneity and is well-suited for bone marrow analysis. Isolated cells can then be characterized by their transcriptomic and epigenetic changes. We will also evaluate EVM cargo (specific proteins/RNA/miR) from both plasma and bone marrow to determine links to chronic stress exposure.
Determine the connection between changes in the microbiome with sympathetic stress-induced changes establishing gut-brain communication following trauma.
Time frame: 3 years
Focusing on the effects of autonomic nervous system on gut function and immune responses, in the setting of sympathetic activation, a serial evaluation of the gut microbiota and their metabolic products (ex. SCFAs: butyrate, propionate, and acetate) will be performed in trauma patients. Correlation of microbial diversity and alterations of the taxonomic composition will be correlated with plasma markers of inflammation and clinical outcomes. Longitudinal study of the trauma pathobiome will elucidate clinical course patterns (recovery and CCI) with microbial composition. The unique biology of the microbiome in different sexes and age groups will require additional subgroup analysis.
Link changes in the microbiome with altered HSPC and erythroid progenitor cells fate establishing gut-bone marrow communication following trauma
Time frame: 3 years
We will examine how stress-induced changes following trauma create a pathobiome that modulates HPSC differentiation and maintains altered erythroid progenitor function. The microbiota play a role in both lineage differentiation and also control systemic iron homeostasis by inhibiting intestinal absorption and increasing cellular iron storage. Bone marrow macrophages have a key role in late-stage erythropoiesis by supplying local iron to erythroblasts for hemoglobin production. Isolation of bone marrow macrophages and erythroblasts involved in EBIs and determination of local iron content will define microbiome-induced changes in terminal erythropoiesis.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- All adults (age ≥18).
- Blunt trauma with an injury severity score \> 15 and a long bone or pelvic fracture requiring open reduction internal fixation or intramedullary fixation
- Blunt trauma patients with shock, defined by either a systolic BP (SBP) \<90 mm Hg or base deficit (BD) ≥5 meq or lactate ≥ 2 mmol/L or active red blood cell or whole blood transfusion within 6h or arrival
Exclusion criteria
- Patients not expected to survive greater than 48 hours
- Previous bone marrow transplantation
- Patients receiving chronic corticosteroids or immunosuppression therapies
- Patients with End Stage Renal Disease
- Patients with any pre-existing hematological disease
- Surgery for repair of injury is greater than seven days after admission to the hospital for trauma
- Burn injury greater than 20% TBSA Elective Hip Cohort Inclusion Criteria
- All adults (age ≥55).
- Patient undergoing elective hip repair for non-infectious reasons.
- Ability to obtain Informed Consent prior to operation. Exclusion Criteria
- Patients not expected to survive greater than 48 hours
- Previous bone marrow transplantation
- Patients receiving chronic corticosteroids or immunosuppression therapies
- Patients with End Stage Renal Disease
- Patients with any pre-existing hematological disease
Where
- Gainesville, Florida
Collaborators
National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
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Data: ClinicalTrials.gov · synced Feb 6, 2026 · Source of record for eligibility and locations