Understanding how trauma affects blood stem cells in elderly patients

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 study investigates the changes in hematopoietic stem cells (HSCs) in elderly patients following severe trauma compared to non-injured individuals. It involves collecting bone marrow and blood samples from three groups: patients undergoing elective hip surgery, trauma patients, and healthy controls. The samples will be analyzed for various parameters, including genomic expression and inflammatory markers, to understand the emergency myelopoiesis response and its implications for recovery and infection susceptibility. Clinical data will also be collected to monitor patient outcomes during hospitalization.

Why it matters

Who can join: the full rules

Severe Trauma Population

Inclusion criteria will be:

1. All adults (age ≥18 to 54)
2. Blunt and/or penetrating trauma resulting in long bone or pelvic fractures requiring ORIF or closed reduction percutaneous pinning (CRPP).
3. Blunt and/or penetrating trauma patient with either:

   1. hemorrhagic shock defined by: i. systolic BP (SBP) ≤ 90 mmHg or ii. mean arterial pressure≤ 65 mmHg or iii. base deficit (BD) ≥ 5 meq or iv. lactate ≥ 2
   2. Or injury severity score (ISS) greater than or equal to 15.
4. All adults (age 55 and older) require:

   1. Blunt and/or penetrating trauma resulting in log bone or pelvic fractures requiring ORIF or CRPP
   2. Either hemorrhagic shock defined by: i. Systolic BP (SBP) ≤ 90 mmHg or ii. Mean arterial pressure ≤ 65 mmHg or iii. Base deficit (BD) ≥5 meq or iv. Lactate ≥ 2
   3. Or Injury Severity Score (ISS) greater than or equal to 15.
5. Ability to obtain Informed Consent prior to OR repair of injury.

Exclusion Criteria will be:

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.

Elective Hip Repair Population

Inclusion criteria will be:

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 will be:

1. Pregnancy.
2. Prisoners.
3. Patients receiving chronic corticosteroids or immunosuppression therapies.
4. History of receiving Chemotherapy or Radiation within the last 6 months
5. Previous bone marrow transplantation

7\. Patients with End Stage Renal Disease 8. Patients with any pre-existing hematological disease

Where it's running

• UF Health Shands Hospital at the University of Florida
  Gainesville, Florida, United States Recruiting

Study contacts

• Principal investigator: Philip Efron, MD — University of Florida
• Study coordinator: Jennifer D Lanz, MSN
• Email: jennifer.lanz@surgery.ufl.edu
• Phone: 352-273-5497

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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.