Understanding blood changes after severe trauma

Pathological Myeloid Activation After Sepsis and Trauma Subtitle: Dysfunctional Myelopoiesis and Myeloid-Derived Suppressor Cells in Sepsis Pathobiology

This study looks at how severe injuries affect blood and bone marrow in trauma patients to see if it changes their immune response compared to patients having planned hip surgeries.

Quick facts

• Study type: Observational
• Enrollment: 255 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: University of Florida (Academic / other)
• Locations: 1 site (Gainesville, Florida)
• Trial ID: NCT05616130 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the effects of severe trauma on blood and bone marrow in patients who have experienced significant injuries. Researchers will collect blood and bone marrow samples from trauma patients undergoing surgical repair and compare their immune responses to those of patients undergoing elective hip surgeries. The study focuses on identifying patterns of hematopoietic stem cell development and the potential for immunosuppression leading to increased risk of sepsis. Participants will also provide medical information and participate in surveys during their recovery.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who have sustained severe blunt or penetrating trauma resulting in significant fractures.

Not a fit: Patients who are not expected to survive beyond 48 hours or those with chronic immunosuppression therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of immune dysfunction in trauma patients, potentially reducing complications like sepsis.

How similar studies have performed: While the specific approach of this study is novel, there is existing literature on trauma-induced immunosuppression that suggests potential for meaningful insights.

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).

Where this trial is running

Gainesville, Florida

• UF Health at Shands Hospital — Gainesville, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Philip Efron, MD — UF COM Department of Surgery
• Study coordinator: Ruth Davis, BSN

Conditions Trauma Injury; Sepsis; Immunosuppression; Chronic Critical Illness