Understanding blood changes after severe trauma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: ruth.davis@surgery.ufl.edu
• Phone: 352-273-8759

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.