NCT06606119 · University of Florida
The Role of Brain-Bone Marrow-Gut Interaction Following Major Trauma
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- Patients not expected to survive greater than 48 hours
- 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
- 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
- Gainesville, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 6, 2026 · Source of record for eligibility and locations