Status:
RECRUITING
The Role of Brain-Bone Marrow-Gut Interaction Following Major Trauma
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Conditions:
Trauma Injury
Trauma
Eligibility:
All Genders
18-100 years
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 im...
Detailed Description
Trauma remains the leading cause of death among people younger than 46 years of age and is the leading cause of years of potential life lost among those younger than 65. With more lives saved, trauma ...
Eligibility Criteria
Inclusion
- Severe Trauma Cohort
- 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
- Patients not expected to survive greater than 48 hours
- Prisoners
- Pregnancy
- 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
- Prisoners
- Pregnancy
- Previous bone marrow transplantation
- Patients receiving chronic corticosteroids or immunosuppression therapies
- Patients with End Stage Renal Disease
- Patients with any pre-existing hematological disease
Key Trial Info
Start Date :
January 24 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT06606119
Start Date
January 24 2025
End Date
October 1 2028
Last Update
January 28 2025
Active Locations (3)
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1
UF Academic Research Building
Gainesville, Florida, United States, 32610
2
UF Health at Shands Hospital
Gainesville, Florida, United States, 32610
3
UF Laboratory of Inflammation Biology and Surgical Science and Shands Hospital at UF
Gainesville, Florida, United States, 32610