NCT05616130 Pathological Myeloid Activation After Sepsis and Trauma
| NCT ID | NCT05616130 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Florida |
| Condition | Trauma Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 255 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 255 participants in total. It began in 2022-09-01 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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).
Contact & Investigator
Philip Efron, MD
PRINCIPAL INVESTIGATOR
UF COM Department of Surgery
Frequently Asked Questions
Who can join the NCT05616130 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Trauma Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05616130 currently recruiting?
Yes, NCT05616130 is actively recruiting participants. Contact the research team at ruth.davis@surgery.ufl.edu for enrollment information.
Where is the NCT05616130 trial being conducted?
This trial is being conducted at Gainesville, United States.
Who is sponsoring the NCT05616130 clinical trial?
NCT05616130 is sponsored by University of Florida. The principal investigator is Philip Efron, MD at UF COM Department of Surgery. The trial plans to enroll 255 participants.