Understanding how trauma affects blood stem cells in elderly patients

Hematopoietic Stem Cell Dysfunction in the Elderly After Severe Injury: Chronic Stress and Anemia Recovery Following Major Trauma

This study looks at how severe trauma affects blood stem cells in older patients to see if it changes their recovery and risk of infections compared to those who haven't been injured.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Florida (Academic / other)
• Drugs / interventions: Chemotherapy, Radiation
• Locations: 1 site (Gainesville, Florida)
• Trial ID: NCT02577731 on ClinicalTrials.gov

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.

Who should consider this trial

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

Not a fit: Patients with minor injuries or those not meeting the trauma criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this research could lead to improved understanding and treatment strategies for elderly patients suffering from severe trauma.

How similar studies have performed: While there have been studies on trauma and stem cell responses, this specific focus on elderly patients and the detailed analysis of HSCs post-trauma is relatively novel.

Eligibility criteria

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 this trial is running

Gainesville, Florida

• 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

Conditions Trauma Injury; Trauma