RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-24
Study Completion:2028-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06606119

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. All adults (age ≥18).
  2. 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. 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
  1. 1. Patients not expected to survive greater than 48 hours
  2. 2. Prisoners
  3. 3. Pregnancy
  4. 4. Previous bone marrow transplantation
  5. 5. Patients receiving chronic corticosteroids or immunosuppression therapies
  6. 6. Patients with End Stage Renal Disease
  7. 7. Patients with any pre-existing hematological disease
  8. 8. Surgery for repair of injury is greater than seven days after admission to the hospital for trauma
  9. 9. Burn injury greater than 20% TBSA
  10. 1. All adults (age ≥55).
  11. 2. Patient undergoing elective hip repair for non-infectious reasons.
  12. 3. Ability to obtain Informed Consent prior to operation.
  13. 1. Patients not expected to survive greater than 48 hours
  14. 2. Prisoners
  15. 3. Pregnancy
  16. 4. Previous bone marrow transplantation
  17. 5. Patients receiving chronic corticosteroids or immunosuppression therapies
  18. 6. Patients with End Stage Renal Disease
  19. 7. Patients with any pre-existing hematological disease

Contacts and Locations

Study Contact

Ruth Davis, BSN
CONTACT
352-273-8759
ruth.davis@surgery.ufl.edu
Jennifer Lanz, MSN
CONTACT
352-273-5497
jennifer.lanz@surgery.ufl.edu

Principal Investigator

Alicia Mohr, MD
PRINCIPAL_INVESTIGATOR
University of Florida

Study Locations (Sites)

UF Academic Research Building
Gainesville, Florida, 32610
United States
UF Health at Shands Hospital
Gainesville, Florida, 32610
United States
UF Laboratory of Inflammation Biology and Surgical Science and Shands Hospital at UF
Gainesville, Florida, 32610
United States

Collaborators and Investigators

Sponsor: University of Florida

  • Alicia Mohr, MD, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-24
Study Completion Date2028-10-01

Study Record Updates

Study Start Date2025-01-24
Study Completion Date2028-10-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Trauma Injury
  • Trauma
  • Critical Illness
  • Microbiome
  • Chronic Anemia
  • Acute Blood Loss Anemia