Pathological Myeloid Activation After Sepsis and Trauma Subtitle: Dysfunctional Myelopoiesis and Myeloid-Derived Suppressor Cells in Sepsis Pathobiology

Status: Recruiting
Location: See location...
Intervention Type: Other, Procedure
Study Type: Observational
SUMMARY

The goal of this observational study is to better understand what happens to circulating blood after a patient experiences severe trauma injury. The main questions it aims to answer are: Is severe human trauma associated with specific patterns of development in the hematopoietic stem cells of these patients? and Does the initial severe trauma injury create immunosuppression and increase risk of in-hospital sepsis? Participants in study will give blood samples and a waste sample of bone marrow at time of operative repair of traumatic orthopedic injuries, supply medical information and participate in surveys and assessments during recovery from their injury(ies). Researchers will compare severe trauma injury patients to elective hip repair patients to see if immunosuppression and specific development patterns occur in the trauma patient versus the otherwise healthy hip surgery patient.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
View:

• All adults age ≥ 18 years

• Blunt and/or penetrating trauma resulting in long bone or pelvic fractures requiring open reduction internal fixation or closed reduction percutaneous pinning

• Blunt and/or penetrating trauma patient with a. Injury Severity Score (ISS) greater than or equal to 25 b. ISS \> 15 and one of the following: i. \> 4 units of packed red blood cell or \>3 units of whole blood or \>1500 ml of autogenous blood product in the first 24 hours of admission ii. AIS (acute injury score) \> 2 spine iii. Shock on arrival (SBP \< 90)

⁃ OR

⁃ c. ISS \> 15 and two of the following: i. Age \> 55 ii. AIS \> 2 chest iii. +ethyl alcohol on arrival iv. Any red blood cell transfusion in first 24 hours

• All adults (age ≥18)

• Patient undergoing elective hip repair for non-infectious reasons.

• Ability to obtain Informed Consent prior to operation.

Locations
United States
Florida
UF Health at Shands Hospital
RECRUITING
Gainesville
Contact Information
Primary
Ruth Davis, BSN
ruth.davis@surgery.ufl.edu
352-273-8759
Backup
Jennifer Lanz, MSN
jennifer.lanz@surgery.ufl.edu
352-273-5497
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2028-09-30
Participants
Target number of participants: 255
Treatments
Trauma
Data collection from medical records; bone marrow collection at time of surgical intervention; serial blood sampling; serial interviews to complete surveys and questionnaires which assess overall health, quality of life, daily living activities and mobility; serial physical function tests - hand grip strength measurement and short physical performance battery and telephone follow up call
Elective Hip Repair
Data collection from medical records; bone marrow collection at time of surgical intervention; serial blood sampling; serial interviews to complete surveys and questionnaires which assess overall health, quality of life, daily living activities and mobility; serial physical function tests - hand grip strength measurement and short physical performance battery and telephone follow up call
Related Therapeutic Areas
Sponsors
Leads: University of Florida
Collaborators: National Institute of General Medical Sciences (NIGMS)

This content was sourced from clinicaltrials.gov