Actively Recruiting

Age: 18Years - 100Years
All Genders
NCT05616130

Pathological Myeloid Activation After Sepsis and Trauma

Led by University of Florida · Updated on 2025-12-26

255

Participants Needed

1

Research Sites

317 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

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.

CONDITIONS

Official Title

Pathological Myeloid Activation After Sepsis and Trauma

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Blunt or penetrating trauma causing long bone or pelvic fractures needing surgical repair
  • Injury Severity Score (ISS) of 25 or higher, or ISS above 15 with specific additional criteria such as blood transfusions, spine or chest injury, shock on arrival, age over 55, alcohol presence, or red blood cell transfusion
  • Adults aged 18 years or older undergoing elective hip repair for non-infectious reasons
  • Ability to give informed consent before surgery
Not Eligible

You will not qualify if you...

  • Patients expected to survive less than 48 hours
  • Prisoners
  • Pregnant individuals
  • Patients on chronic corticosteroids or immunosuppressive treatments
  • History of bone marrow transplantation
  • Patients with end-stage renal disease
  • Pre-existing hematological diseases
  • Patients receiving futile care or with advanced directives limiting resuscitation
  • Severe congestive heart failure (NYHA Class IV)
  • Known HIV infection with CD4 count below 200 cells/mm3
  • Chronic liver disease with MELD score of 15 or higher
  • Patients with pathological fractures, cancer, HIV history, or connective tissue disease (elective hip group)
  • Known active or symptomatic COVID-19 infection (elective hip group)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

UF Health at Shands Hospital

Gainesville, Florida, United States, 32610

Actively Recruiting

Loading map...

Research Team

R

Ruth Davis, BSN

CONTACT

J

Jennifer Lanz, MSN

CONTACT

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here