The Role of Brain-Bone Marrow-Gut Interaction Following Major Trauma
Part of paid clinical trials in Gainesville, Florida.
- Sponsor
- University of Florida
- Study ID
- NCT06606119
- Status
- Recruiting
Conditions
- Acute Blood Loss Anemia
- Chronic Anemia
- Critical Illness
- Microbiome
- Trauma
- Trauma Injury
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 100 Years
- Healthy Volunteers
- Not accepted
Interventions
- Data and tissue collection — OTHERCollection of bone marrow, blood, feces, medical record data, and patient response surveys.
Study Details
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 Dates
- Start date
- Jan 24, 2025
- Status verified
- Feb 2026
- Primary completion
- Oct 1, 2027
- Completion
- Oct 1, 2028
Study Design
- Enrollment
- 275 participants (estimated)
Arms
- Arm: Major Trauma InjurySevere blunt trauma patients diagnosed with shock with a long bone or pelvic fracture requiring open reduction internal fixation or intramedullary fixation.
- Arm: Elective Hip ReplacementPatients undergoing elective hip replacement surgery
Primary Outcome Measure
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 ]
Central Contacts
- Ruth Davis, BSN352-273-8759
- Jennifer Lanz, MSN352-273-5497
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UF Academic Research Building | Gainesville | Florida | 32610 | |
| UF Health at Shands Hospital | Gainesville | Florida | 32610 | Jennifer Lanz, MSN 352-273-5497 Alicia Mohr, MD (PRINCIPAL_INVESTIGATOR) |
| UF Laboratory of Inflammation Biology and Surgical Science and Shands Hospital at UF | Gainesville | Florida | 32610 | Alicia L Mohr, MD (PRINCIPAL_INVESTIGATOR) |
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