Understanding how trauma affects the gut and bone marrow

The Role of Brain-Bone Marrow-Gut Interaction Following Major Trauma

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
• Enrollment: 275 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: University of Florida (Academic / other)
• Locations: 3 sites (Gainesville, Florida and 2 other locations)
• Trial ID: NCT06606119 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who have experienced severe blunt trauma with significant injuries.

Not a fit: Patients not expected to survive beyond 48 hours or those with pre-existing hematological diseases may not benefit from this study.

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 performed: 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.

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

Where this trial is running

Gainesville, Florida and 2 other locations

• 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

Conditions Trauma Injury; Trauma; Critical Illness; Microbiome; Chronic Anemia; Acute Blood Loss Anemia; Hematopoietic Stem Progenitor Cells; Bone Marrow Failure