Trauma InjuryNCT05616130
Pathological Myeloid Activation After Sepsis and Trauma
An observational study of Trauma Injury and Sepsis, run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Trauma Injury, Sepsis, Immunosuppression
- What is being tested?
- Data Collection, Bone marrow collection and blood collection and Serial interviews to complete surveys and questionnaires
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 255 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 30 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
- 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
- All adults (age ≥18)
- Patient undergoing elective hip repair for non-infectious reasons.
- Ability to obtain Informed Consent prior to operation.
Who cannot join
- 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.
Show all 20Show fewer
- 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
- Pregnancy.
- Prisoners.
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UF Health at Shands Hospital
Gainesville, Florida, 32610
Ruth Davis, BSN, 352-273-8759, ruth.davis@surgery.ufl.edu
Jennifer Lanz, MSN, 352-273-5497
About this study
Official title: Pathological Myeloid Activation After Sepsis and Trauma Subtitle: Dysfunctional Myelopoiesis and Myeloid-Derived Suppressor Cells in Sepsis Pathobiology
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.
Read the detailed description
Severe trauma is linked with challenging clinical trajectories as well as dismal long-term outcomes following hospital discharge. In surgical intensive care units, an alarming percentage of trauma patients can develop chronic critical illness (CCI), a prolonged acute-care and chronic-care hospitalization with unresolved organ dysfunction. CCI frequently manifests as a persistent inflammation, immunosuppression and catabolism syndrome (PICS). Trauma survivors suffering from PICS have repeat infections, poor cognitive performance, physical dysfunction and self-reported poor quality of life. These conditions, at least in part, are due to an unresolving pathologic myelopoiesis and ensuing prevalence of distinct myeloid-derived suppressor cells (MDSCs). The investigator's laboratory has also discovered key distinctions in these MDSCs' accompanying pathologic myeloid activation, while concurrently, they produce inflammatory cytokines, reactive nitric oxide (NO), oxidation and peroxidation products that damage parenchymal cells and promote inflammation. In addition, there are hematopoietic stem and progenitor cells (HSPCs), from which these white blood cells are derived, in the bone marrow and blood that contribute to the development of these dysfunctional cells. The investigators hypothesize that epigenetic alterations and immunometabolism affect each other in relation to the development and suppressive activity of these MDSCs. The overarching goal is to build upon this foundation and expand our understanding of the patient immune response to trauma. The investigator's goal is to define the key aspects of MDSC and HSPC pathophysiology that engender and maintain pathologic myeloid activation and its pathology after trauma and subsequently modify these systems to mitigate or prevent chronic critical illness and persistent inflammation, immunosuppression and catabolism syndrome. Identification is done through direct data collection from participants and collection of blood over a 6 month period and a one-time bone marrow collection at time of trauma surgery repair and elective hip repair.
- Conditions
- Trauma Injury, Sepsis, Immunosuppression, Chronic Critical Illness
- Being tested
- Data Collection, Bone marrow collection and blood collection, Serial interviews to complete surveys and questionnaires, Telephone follow up call
- Medical subject headings
- Accidental Injuries, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data CollectionOther
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)
Bone marrow collection and blood collectionProcedure or surgery
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.
Serial interviews to complete surveys and questionnairesOther
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.
Telephone follow up callOther
Also called Telephone interview
The study team will contact you at 12 months to complete a telephone interview to learn about your health and well being.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Data Collection; Procedure: Bone marrow collection and blood collection; Other: Serial interviews to complete surveys and questionnaires; Other: 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 Receives: Other: Data Collection; Procedure: Bone marrow collection and blood collection; Other: Serial interviews to complete surveys and questionnaires; Other: Telephone follow up call |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start1 Sep 2022
- Primary completion1 Sep 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma InjuryStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Philip Efron, MD, Principal investigator, UF COM Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616130
- Sponsor's protocol ID
- IRB202100572
- Other IDs
- RM1GM139690, R35GM140806
- Status last verified
- Dec 2025
- First submitted
- 7 Nov 2022
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathological Myeloid Activation After Sepsis and Trauma Subtitle: Dysfunctional Myelopoiesis and Myeloid-Derived Suppressor Cells in Sepsis Pathobiology
- ClinicalTrials.gov ID
- NCT05616130
- Acronym / sponsor ID
- IRB202100572
- Conditions
- Trauma Injury, Sepsis, Immunosuppression, Chronic Critical Illness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 15 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Severe trauma is linked with challenging clinical trajectories as well as dismal long-term outcomes following hospital discharge. In surgical intensive care units, an alarming percentage of trauma patients can develop chronic critical illness (CCI), a prolonged acute-care and chronic-care hospitalization with unresolved organ dysfunction. CCI frequently manifests as a persistent inflammation, immunosuppression and catabolism syndrome (PICS). Trauma survivors suffering from PICS have repeat infections, poor cognitive performance, physical dysfunction and self-reported poor quality of life. These conditions, at least in part, are due to an unresolving pathologic myelopoiesis and ensuing prevalence of distinct myeloid-derived suppressor cells (MDSCs). The investigator's laboratory has also discovered key distinctions in these MDSCs' accompanying pathologic myeloid activation, while concurrently, they produce inflammatory cytokines, reactive nitric oxide (NO), oxidation and peroxidation products that damage parenchymal cells and promote inflammation. In addition, there are hematopoietic stem and progenitor cells (HSPCs), from which these white blood cells are derived, in the bone marrow and blood that contribute to the development of these dysfunctional cells. The investigators hypothesize that epigenetic alterations and immunometabolism affect each other in relation to the development and suppressive activity of these MDSCs. The overarching goal is to build upon this foundation and expand our understanding of the patient immune response to trauma. The investigator's goal is to define the key aspects of MDSC and HSPC pathophysiology that engender and maintain pathologic myeloid activation and its pathology after trauma and subsequently modify these systems to mitigate or prevent chronic critical illness and persistent inflammation, immunosuppression and catabolism syndrome. Identification is done through direct data collection from participants and collection of blood over a 6 month period and a one-time bone marrow collection at time of trauma surgery repair and elective hip repair.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trauma | – | Other: Data Collection, Procedure: Bone marrow collection and blood collection, Other: Serial interviews to complete surveys and questionnaires, Other: Telephone follow up callData 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 | – | Other: Data Collection, Procedure: Bone marrow collection and blood collection, Other: Serial interviews to complete surveys and questionnaires, Other: Telephone follow up callData 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- 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
- 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
Key exclusion criteria (20 listed)
- Patients not expected to survive greater than 48 hours.
- Prisoners.
- Pregnancy.
- Patients receiving chronic corticosteroids or immunosuppression therapies.
- Previous bone marrow transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data CollectionResearcher 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) | Other | Elective Hip Repair, Trauma |
| Bone marrow collection and blood collectionAt 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. | Procedure or surgery | Elective Hip Repair, Trauma |
| Serial interviews to complete surveys and questionnairesParticipants 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. | Other | Elective Hip Repair, Trauma |
| Telephone follow up callAlso: Telephone interviewThe study team will contact you at 12 months to complete a telephone interview to learn about your health and well being. | Other | Elective Hip Repair, Trauma |
Primary outcome
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.
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philip Efron, MD principal investigator
UF COM Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma Injury and Sepsis, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruth Davis, BSN (352-273-8759, ruth.davis@surgery.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Through study completion, an average of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.