Pathological Myeloid Activation After Sepsis and Trauma

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorUniversity of Florida

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

Patients not expected to survive greater than 48 hours.

Prisoners.

Pregnancy.

Patients receiving chronic corticosteroids or immunosuppression therapies.

Trial design

Treatments tested in this trial

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

Treatment groups

255 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Florida

Lead sponsor

National Institute of General Medical Sciences (NIGMS)

Collaborator