Recruiting

Observational Study

Sponsor:

University of Florida

Code:

NCT06606119

Conditions

Trauma Injury

Trauma

Critical Illness

Microbiome

Chronic Anemia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Data and tissue collection

Study Details

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.

Conditions

Trauma Injury

Trauma

Critical Illness

Microbiome

Chronic Anemia

Study ID

NCT06606119

Start date

Jan 24, 2025

Status verified date

Feb, 2026

Completion date

Oct 1, 2028

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

275 participants

Anticipated

Interventions and Outcome Measures

Arms

Major Trauma Injury

Severe blunt trauma patients diagnosed with shock with a long bone or pelvic fracture requiring open reduction internal fixation or intramedullary fixation.

Elective Hip Replacement

Patients undergoing elective hip replacement surgery

Interventions

Data and tissue collection

Collection of bone marrow, blood, feces, medical record data, and patient response surveys.

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 ]
  • Determine the connection between changes in the microbiome with sympathetic stress-induced changes establishing gut-brain communication following trauma. [ Time Frame: 3 years ]
  • Link changes in the microbiome with altered HSPC and erythroid progenitor cells fate establishing gut-bone marrow communication following trauma [ Time Frame: 3 years ]

Central Contacts and Locations

Locations

UF Academic Research Building

Recruiting

Gainesville, Florida, United States, 32610

Contacts

UF Health at Shands Hospital

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Principal Investigator:

Alicia Mohr, MD

UF Laboratory of Inflammation Biology and Surgical Science and Shands Hospital at UF

Recruiting

Gainesville, Florida, United States, 32610

Principal Investigator:

Alicia L Mohr, MD

More Information

Sponsor

University of Florida

Last update posted

Feb 6, 2026

Last verified

Feb, 2026

Keywords

  • Hematopoietic Stem Progenitor Cells
  • Bone Marrow Failure
  • Anemia
  • Gut Microbiome
  • Inflammation
  • Dysregulated Stress Response

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-02-06.