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Pathological Myeloid Activation After Sepsis and Trauma

Recruitingn/aAges 18 Years - 100 YearsAllUniversity of Florida
NCT05616130 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Trauma population Inclusion Criteria: 1. All adults age ≥ 18 years 2. Blunt and/or penetrating trauma resulting in long bone or pelvic fractures requiring open reduction internal fixation or closed reduction percutaneous pinning 3. 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 Exclusion Criteria: 1. Patients not expected to survive greater than 48 hours. 2. Prisoners. 3. Pregnancy. 4. Patients receiving chronic corticosteroids or immunosuppression therapies. 5. Previous bone marrow transplantation. 6. Patients with End Stage Renal Disease. 7. Patients with any pre-existing hematological disease. 8. Patients deemed to be futile care or have advanced directives limiting resuscitative efforts. 9. Patients with severe congestive heart failure (NY Heart Association Class IV). 10. Known HIV infection with CD4+ (clusters of differentiation) count \<200 cells/mm3 11. Chronic liver disease with MELD (Model for End-Stage Liver Disease) score ≥15 Elective Hip population Inclusion Criteria: 1. All adults (age ≥18) 2. Patient undergoing elective hip repair for non-infectious reasons. 3. Ability to obtain Informed Consent prior to operation. Exclusion Criteria: 1. Pregnancy. 2. Prisoners. 3. Patients receiving chronic corticosteroids or immunosuppression therapies. 4. Pre-existing conditions such as pathological fractures, cancer, history of HIV, or history of connective tissue disease. 5. Previous bone marrow transplantation. 6. Patients with End Stage Renal Disease. 7. Patients with any pre-existing hematological disease. 8. Patients with known active/symptomatic COVID-19 (Coronavirus disease).
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What it tests

  • Data Collection
  • Bone marrow collection and blood collection
  • Serial interviews to complete surveys and questionnaires
  • Telephone follow up call
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Where

1 site
UF Health at Shands Hospital
Gainesville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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