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Search / Trial NCT06606119

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

Launched by UNIVERSITY OF FLORIDA · Sep 18, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

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

ClinConnect Summary

This clinical trial is studying how major trauma, like severe injuries from accidents, affects the body, particularly the interactions between the brain, bone marrow, and gut. After a traumatic injury, patients often experience problems such as anemia (low red blood cell count) and changes in the gut bacteria, which can hinder their recovery. The researchers aim to understand how stress, inflammation, and other factors contribute to these issues, with the hope that this knowledge will lead to better treatments and outcomes for patients following severe injuries.

To participate in this trial, you need to be an adult aged 18 or older who has experienced significant blunt trauma—such as a serious car accident or a fall—that resulted in specific injuries. For example, you might have a broken bone that needs surgery right away. There is also a separate group for older adults (55 and older) undergoing planned hip surgeries. Participants can expect to receive careful monitoring and care throughout the study, and your involvement will help researchers learn more about recovery after serious trauma. It's important to know that certain health conditions or circumstances may prevent someone from joining the trial, such as being pregnant or having severe kidney disease.

Gender

ALL

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

About University Of Florida

The University of Florida, a leading research institution, is dedicated to advancing healthcare through innovative clinical trials. With a focus on enhancing patient outcomes and exploring new therapeutic avenues, the university leverages its extensive resources, interdisciplinary expertise, and state-of-the-art facilities to conduct rigorous research across a variety of medical fields. Committed to ethical standards and patient safety, the University of Florida fosters collaboration among researchers, healthcare professionals, and community stakeholders to translate scientific discoveries into impactful clinical applications.

Locations

Gainesville, Florida, United States

Gainesville, Florida, United States

Gainesville, Florida, United States

Patients applied

0 patients applied

Trial Officials

Alicia Mohr, MD

Principal Investigator

University of Florida

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported