NCT05616130 · University of Florida
Pathological Myeloid Activation After Sepsis and Trauma
What this study is about
The goal of this observational study is to better understand what happens to circulating blood after a patient experiences severe trauma injury.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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) 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
- Patients not expected to survive greater than 48 hours.
- Patients receiving chronic corticosteroids or immunosuppression therapies.
- Previous bone marrow transplantation.
- Patients with End Stage Renal Disease.
- Patients with any pre-existing hematological disease.
- Patients deemed to be futile care or have advanced directives limiting resuscitative efforts.
- Patients with severe congestive heart failure (NY Heart Association Class IV).
- Known HIV infection with CD4+ (clusters of differentiation) count \<200 cells/mm3
- Chronic liver disease with MELD (Model for End-Stage Liver Disease) score ≥15 Elective Hip population Inclusion Criteria:
- All adults (age ≥18)
- Patient undergoing elective hip repair for non-infectious reasons.
- Ability to obtain Informed Consent prior to operation. Exclusion Criteria:
- Patients receiving chronic corticosteroids or immunosuppression therapies.
- Pre-existing conditions such as pathological fractures, cancer, history of HIV, or history of connective tissue disease.
- Previous bone marrow transplantation.
- Patients with End Stage Renal Disease.
- Patients with any pre-existing hematological disease.
- Patients with known active/symptomatic COVID-19 (Coronavirus disease).
Where
- Gainesville, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 26, 2025 · Source of record for eligibility and locations