The Role of Brain-Bone Marrow-Gut Interaction Following Major Trauma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorUniversity of Florida
About this trial
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
Qualifiers
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
Disqualifiers
Patients not expected to survive greater than 48 hours
Prisoners
Pregnancy
Previous bone marrow transplantation
Trial design
Treatments tested in this trial
- Data and tissue collection
Treatment groups
275 Participants
are divided into 2 treatment groupsLocations
3UF Academic Research Building32610, GainesvilleFlorida, United States
UF Health at Shands Hospital32610, GainesvilleFlorida, United States
UF Laboratory of Inflammation Biology and Surgical Science and Shands Hospital at UF32610, GainesvilleFlorida, United States
Sponsors and collaborators
University of Florida
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute of General Medical Sciences (NIGMS)
Collaborator
Source ClinicalTrials.gov