The Role of Brain-Bone Marrow-Gut Interaction Following Major Trauma
Recruiting now
Conditions studied: Trauma Injury, Trauma, Critical Illness, Microbiome, Chronic Anemia, Acute Blood Loss Anemia
In brief
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.
Key facts
- Study ID
- NCT06606119
- Run by
- University of Florida
- People needed
- 275
- Starts
- 2025-01-24
- Expected to finish
- 2028-10-01
- Last updated by the study team
- 2026-02-06
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Patients not expected to survive greater than 48 hours
- Prisoners
- Pregnancy
- 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
- Prisoners
- Pregnancy
- 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 it is running
- UF Academic Research Building — Gainesville, Florida, United States (enrolling)
- UF Health at Shands Hospital — Gainesville, Florida, United States (enrolling)
- UF Laboratory of Inflammation Biology and Surgical Science and Shands Hospital at UF — Gainesville, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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