Actively Recruiting
Pathological Myeloid Activation After Sepsis and Trauma Dysfunctional Myelopoiesis and Myeloid-Derived Suppressor Cells in Sepsis Pathobiology
Led by University of Florida · Updated on 2025-12-26
255
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
N
National Institute of General Medical Sciences (NIGMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how severe trauma injuries affect blood cells and the immune system. The study aims to understand if trauma changes the development of blood stem cells and causes immunosuppression that may increase the risk of infections like sepsis during hospital stays. They will compare trauma patients with patients undergoing elective hip repair to see differences in immune response and blood cell behavior. Participants will provide blood samples and a bone marrow sample during surgery for their traumatic injury or elective hip repair. Blood samples will also be collected at surgery, day 14 or hospital discharge, and at 3 and 6 months after surgery. Participants will complete surveys and questionnaires to assess health, quality of life, daily activities, and mobility. Physical function tests such as hand grip strength and a short physical performance battery will be done, along with telephone follow-up at 12 months. Throughout the study, researchers will collect medical record data including vital signs, medications, infections, and treatment outcomes. Participants will be monitored for changes in immune cells and risk of sepsis. The main outcome is to test whether trauma leads to immunosuppressive changes in bone marrow stem cells that increase sepsis risk. The study will last about 12 months, with multiple assessments during recovery to track health and immune function over time.
CONDITIONS
Brief Title
Pathological Myeloid Activation After Sepsis and Trauma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults age 18 years or older
- Blunt or penetrating trauma causing long bone or pelvic fractures requiring surgery
- Injury Severity Score (ISS) ≥ 25, or ISS > 15 with specific blood transfusions, spine injury, shock on arrival, or other risk factors
- Adults age 18 years or older undergoing elective hip repair for non-infectious reasons
- Ability to provide informed consent before surgery
You will not qualify if you...
- Patients unlikely to survive more than 48 hours
- Prisoners
- Pregnant individuals
- Patients on chronic corticosteroids or immunosuppressive therapies
- Previous bone marrow transplant recipients
- Patients with end-stage renal disease
- Patients with pre-existing blood disorders
- Patients receiving futile care or with advanced directives limiting resuscitation
- Severe congestive heart failure (NYHA Class IV)
- Known HIV infection with low CD4 count (<200 cells/mm3)
- Chronic liver disease with MELD score ≥ 15
- Patients with pathological fractures, cancer, connective tissue diseases, or symptomatic COVID-19 (for elective hip repair group)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
At the time of scheduled surgery, participants undergo bone marrow and blood collection to provide samples for research on immune response to trauma.
1 visit (in-person, surgery day)
Duration - Up to 6 months
Participants undergo serial blood collections and complete surveys assessing health, quality of life, daily activities, and mobility during the hospital stay and through follow-up visits.
Blood collection and surveys at day 14 or discharge, 3 months, and 6 months
Duration - 12 months after surgery
Participants receive a telephone interview to assess health and well-being at 12 months after surgery.
1 telephone follow-up call
Trial Site Locations
Total: 1 location
1
UF Health at Shands Hospital
Gainesville, Florida, United States, 32610
Actively Recruiting
Research Team
R
Ruth Davis, BSN
J
Jennifer Lanz, MSN
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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