Pathological Myeloid Activation After Sepsis and Trauma
3 other identifiers
observational
255
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2022
CompletedFirst Submitted
Initial submission to the registry
November 7, 2022
CompletedFirst Posted
Study publicly available on registry
November 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2028
December 26, 2025
December 1, 2025
5 years
November 7, 2022
December 23, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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.
Through study completion, an average of 12 months
Study Arms (2)
Trauma
Data collection from medical records; bone marrow collection at time of surgical intervention; serial blood sampling; serial interviews to complete surveys and questionnaires which assess overall health, quality of life, daily living activities and mobility; serial physical function tests - hand grip strength measurement and short physical performance battery and telephone follow up call
Elective Hip Repair
Data collection from medical records; bone marrow collection at time of surgical intervention; serial blood sampling; serial interviews to complete surveys and questionnaires which assess overall health, quality of life, daily living activities and mobility; serial physical function tests - hand grip strength measurement and short physical performance battery and telephone follow up call
Interventions
Researcher will collect data from subject's medical records: information regarding your medical history, trauma injury, heart rate, blood pressure, temperature (vital signs), use of antibiotics (medications used to treat infection) and other medications, development of infection, and treatment results will be recorded and kept with your research records. Demographic information (such as name, address, phone number, gender, race, height and weight, age and birth date), medical record notes (including but not limited to history and physical exam notes, progress notes, consultation reports, laboratory test results, operative reports, information relating to acquired immunodeficiency virus (HIV) infection, radiologic (x-ray studies) results, and blood samples)
At time of scheduled surgery, researcher will collect a 20ml (approximately 4 teaspoons) sample of bone marrow while you are in the operating room receiving surgery for your orthopedic (bone) injuries or elective hip repair. Blood collection will occur at time of surgery, day 14 on study or discharge from hospital and at 3 and 6 months. Up to 58 ml (about 4 tablespoons) sample of blood will be collected from an existing intravenous line or peripheral needle stick.
Participants will be asked to complete questionnaires and surveys that assess your health, quality of life, daily living activities, and mobility. These activities occur at enrollment, day 14 in hospital or discharge, and at the 3, 6, and 12-month visits.
The study team will contact you at 12 months to complete a telephone interview to learn about your health and well being.
Eligibility Criteria
Patients admitted to surgical and trauma intensive care units who have suffered severe trauma with major orthopedic injury requiring open reduction and internal fixation of the broken bone. Patients seeking an elective hip repair at the UF Orthopedic Sports Medicine Institute.
You may qualify if:
- 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)
- 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
You may not qualify if:
- Patients not expected to survive greater than 48 hours.
- Prisoners.
- Pregnancy.
- 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
- All adults (age ≥18)
- Patient undergoing elective hip repair for non-infectious reasons.
- Ability to obtain Informed Consent prior to operation.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UF Health at Shands Hospital
Gainesville, Florida, 32610, United States
Biospecimen
Blood Bone Marrow
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philip Efron, MD
UF COM Department of Surgery
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2022
First Posted
November 15, 2022
Study Start
September 1, 2022
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 30, 2028
Last Updated
December 26, 2025
Record last verified: 2025-12