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Observational Study on Myeloid Activation After Sepsis and Trauma

This observational study aims to understand how severe trauma injuries affect your body's immune system, specifically focusing on certain blood cells (myeloid cells). Researchers want to see if severe trauma leads to a weakened immune system (immunosuppression) and increases your risk of getting infections in the hospital (sepsis). You can join if you are an adult aged 18 to 100 years old and have experienced a trauma injury, such as a broken bone, that requires surgery. The study will collect information from your medical records, take blood and a small bone marrow sample during your surgery, and ask you to complete surveys about your health and quality of life over 12 months. The main goal is to learn if your body's initial response to trauma is linked to a higher risk of sepsis and changes in your bone marrow cells.

Study design
This is an observational study with a planned enrollment of 255 participants. It is not a treatment study, but rather aims to understand how the body responds to trauma.
What's involved
You would provide medical record data, give blood and a bone marrow sample during surgery, and complete surveys at enrollment, hospital discharge or day 14, and at 3, 6, and 12 months, with a final telephone call at 12 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for an average of 12 months after enrollment, with the primary endpoint measured through study completion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05616130

Pathological Myeloid Activation After Sepsis and Trauma

Recruiting
Not specifiedAges 18+Observational
University of Florida
~255 participants
Updated 2025-12-26 on ClinicalTrials.gov
What's tested:Data CollectionBone marrow collection and blood collectionSerial interviews to complete surveys and questionnairesTelephone follow up call

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over Through study completion, an average of 12 months

Conditions

Trauma Injury
Sepsis
Immunosuppression
Chronic Critical Illness

Explore related trials

Critical IllnessImmunosuppressive TherapyInjurySepticemia

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Philip Efron, MD · PRINCIPAL_INVESTIGATOR · UF COM Department of Surgery

Who to contact

Ruth Davis, BSN
[email protected]
352-273-8759
Email the study team

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What this trial measures

  • 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.Through study completion, an average of 12 months

    With subsequent sepsis development, MDSCs induce their continued expansion through exocrine and paracrine signaling to HSPCs. HSPCs and MDSCs derived from severe blunt trauma patients will be analyzed for epigenetic (MAPit DNA methylation) and functional changes (ability to generate colony forming units (CFUs)) that initiate sepsis and continue the expansion of immunosuppressive MDSCs.