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The Role of Brain-Bone Marrow-Gut Interaction Following Major Trauma
Who can join
Ages 18 to 100 · All sexes
Full eligibility 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
About the study
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.
What is being tested
- Data and tissue collection (other)
Sponsor: University of Florida · Participants: 275 · Started: Jan 24, 2025
Contact the study team
- Ruth Davis, BSN · Phone: 352-273-8759
- Jennifer Lanz, MSN · Phone: 352-273-5497
Official record on ClinicalTrials.gov — NCT06606119
Locations in the U.S.
| Florida | UF Academic Research Building, Gainesville UF Health at Shands Hospital, Gainesville UF Laboratory of Inflammation Biology and Surgical Science and Shands Hospital at UF, Gainesville |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.