Recruiting

Observational Study

Sponsor:

University of Florida

Code:

NCT05616130

Conditions

Trauma Injury

Sepsis

Immunosuppression

Chronic Critical Illness

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Data Collection

Bone marrow collection and blood collection

Serial interviews to complete surveys and questionnaires

Telephone follow up call

Study Details

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.

Conditions

Trauma Injury

Sepsis

Immunosuppression

Chronic Critical Illness

Study ID

NCT05616130

Start date

Sep 1, 2022

Status verified date

Dec, 2025

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

255 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Data Collection

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 collection

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 questionnaires

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 call

The study team will contact you at 12 months to complete a telephone interview to learn about your health and well being.

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 ]

Central Contacts and Locations

Central contacts

Ruth Davis, BSN

352-273-8759ruth.davis@surgery.ufl.edu

Jennifer Lanz, MSN

352-273-5497jennifer.lanz@surgery.ufl.edu

Locations

UF Health at Shands Hospital

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Ruth Davis, BSN

352-273-8759ruth.davis@surgery.ufl.edu

Jennifer Lanz, MSN

352-273-5497

Principal Investigator:

Philip Efron, MD

More Information

Sponsor

University of Florida

Last update posted

Dec 26, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2025-12-26.