NCT06606119 The Role of Brain-Bone Marrow-Gut Interaction Following Major Trauma
| NCT ID | NCT06606119 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Florida |
| Condition | Trauma Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 275 participants |
| Start Date | 2025-01-24 |
| Primary Completion | 2027-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 275 participants in total. It began in 2025-01-24 with a primary completion date of 2027-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Alicia Mohr, MD
PRINCIPAL INVESTIGATOR
University of Florida
Frequently Asked Questions
Who can join the NCT06606119 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Trauma Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06606119 currently recruiting?
Yes, NCT06606119 is actively recruiting participants. Contact the research team at ruth.davis@surgery.ufl.edu for enrollment information.
Where is the NCT06606119 trial being conducted?
This trial is being conducted at Gainesville, United States, Gainesville, United States, Gainesville, United States.
Who is sponsoring the NCT06606119 clinical trial?
NCT06606119 is sponsored by University of Florida. The principal investigator is Alicia Mohr, MD at University of Florida. The trial plans to enroll 275 participants.