Understanding how trauma affects the gut and bone marrow
Official title: The Role of Brain-Bone Marrow-Gut Interaction Following Major Trauma
Run by University of Florida · NCT06606119 · Data updated 2026-11-12
This study looks at how stress and inflammation after a major trauma affect the gut and bone marrow to see if they contribute to ongoing anemia and recovery issues in trauma survivors.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 275 (estimated) |
| Sponsor | University of Florida Academic / other |
| Locations | 3 sites (Gainesville, Florida and 2 other locations) |
| Status | Recruiting |
| Started | January 24, 2025 |
| Main results expected | October 1, 2027 |
| Study ends | October 1, 2028 |
| Registry record updated | February 6, 2026 |
| Trial ID | NCT06606119 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older who have experienced severe blunt trauma with significant injuries.
✕Probably not a fit
Patients not expected to survive beyond 48 hours or those with pre-existing hematological diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the interactions between stress, chronic inflammation, and bone marrow dysfunction following major trauma. It focuses on how these factors contribute to persistent anemia and changes in the gut microbiome, which can significantly impact long-term recovery. By collecting data and tissue samples from patients who have experienced severe trauma, the study aims to establish a foundation for future clinical interventions that could improve outcomes for trauma survivors.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery strategies for patients suffering from the long-term effects of severe trauma.
How similar studies have gone: While the specific interactions being studied may be novel, previous research has indicated that understanding the relationship between trauma, inflammation, and recovery can lead to meaningful advancements in patient care.
Who can join: the full rules
Show full inclusion / exclusion criteria
Severe Trauma Cohort Inclusion Criteria: 1. All adults (age ≥18). 2. Blunt trauma with an injury severity score \> 15 and a long bone or pelvic fracture requiring open reduction internal fixation or intramedullary fixation 3. 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: 1. Patients not expected to survive greater than 48 hours 2. Prisoners 3. Pregnancy 4. Previous bone marrow transplantation 5. Patients receiving chronic corticosteroids or immunosuppression therapies 6. Patients with End Stage Renal Disease 7. Patients with any pre-existing hematological disease 8. Surgery for repair of injury is greater than seven days after admission to the hospital for trauma 9. Burn injury greater than 20% TBSA Elective Hip Cohort Inclusion Criteria 1. All adults (age ≥55). 2. Patient undergoing elective hip repair for non-infectious reasons. 3. Ability to obtain Informed Consent prior to operation. Exclusion Criteria 1. Patients not expected to survive greater than 48 hours 2. Prisoners 3. Pregnancy 4. Previous bone marrow transplantation 5. Patients receiving chronic corticosteroids or immunosuppression therapies 6. Patients with End Stage Renal Disease 7. Patients with any pre-existing hematological disease
Where it's running
-
UF Academic Research Building
Gainesville, Florida, United States Recruiting -
UF Health at Shands Hospital
Gainesville, Florida, United States Recruiting -
UF Laboratory of Inflammation Biology and Surgical Science and Shands Hospital at UF
Gainesville, Florida, United States Recruiting
Study contacts
- Principal investigator: Alicia Mohr, MD — University of Florida
- Study coordinator: Ruth Davis, BSN
- Email: ruth.davis@surgery.ufl.edu
- Phone: 352-273-8759
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.