Pathological Myeloid Activation After Sepsis and Trauma

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT05616130
Status
Recruiting
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Conditions

  • Chronic Critical Illness
  • Immunosuppression
  • Sepsis
  • Trauma Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Data Collection — OTHER
    Researcher will collect data from subject's medical records: information regarding your medical history, trauma injury, heart rate, blood pressure, temperature (vital signs), use of antibiotics (medications used to treat infection) and other medications, development of infection, and treatment results will be recorded and kept with your research records. Demographic information (such as name, address, phone number, gender, race, height and weight, age and birth date), medical record notes (including but not limited to history and physical exam notes, progress notes, consultation reports, laboratory test results, operative reports, information relating to acquired immunodeficiency virus (HIV) infection, radiologic (x-ray studies) results, and blood samples)
  • Bone marrow collection and blood collection — PROCEDURE
    At time of scheduled surgery, researcher will collect a 20ml (approximately 4 teaspoons) sample of bone marrow while you are in the operating room receiving surgery for your orthopedic (bone) injuries or elective hip repair. Blood collection will occur at time of surgery, day 14 on study or discharge from hospital and at 3 and 6 months. Up to 58 ml (about 4 tablespoons) sample of blood will be collected from an existing intravenous line or peripheral needle stick.
  • Serial interviews to complete surveys and questionnaires — OTHER
    Participants will be asked to complete questionnaires and surveys that assess your health, quality of life, daily living activities, and mobility. These activities occur at enrollment, day 14 in hospital or discharge, and at the 3, 6, and 12-month visits.
  • Telephone follow up call — OTHER
    The study team will contact you at 12 months to complete a telephone interview to learn about your health and well being.

Study Details

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.

Key Dates

Start date
Sep 1, 2022
Status verified
Dec 2025
Primary completion
Sep 1, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
255 participants (estimated)

Arms

  • Arm: 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
  • Arm: 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

Primary Outcome Measure

Test hypothesis that response to initial stimulus (trauma) is associated with a high risk of inhospital sepsis, the bone marrow (BM) hematopoietic stem and progenitor cells (HSPCs) promote immunosuppressive myelopoiesis at the expense of lymphopoiesis. [ Time Frame: Through study completion, an average of 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UF Health at Shands HospitalGainesvilleFlorida32610
Ruth Davis, BSN
[email protected]
352-273-8759
Jennifer Lanz, MSN
352-273-5497
Philip Efron, MD (PRINCIPAL_INVESTIGATOR)

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By research site
UF Health at Shands Hospital· Gainesville, FL

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