Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT02577731

Hematopoietic Stem Cell Dysfunction in the Elderly After Severe Injury

Led by University of Florida · Updated on 2026-01-15

400

Participants Needed

1

Research Sites

730 weeks

Total Duration

On this page

Sponsors

U

University of Florida

Lead Sponsor

N

National Institute of General Medical Sciences (NIGMS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Traumatic injury is a leading cause of morbidity and mortality in young adults, and remains a substantial economic and health care burden. Despite decades of promising preclinical and clinical investigations in trauma, investigators understanding of these entities is still incomplete, and few therapies have shown success. During severe trauma, bone marrow granulocyte stores are rapidly released into the peripheral circulation. This release subsequently induces the expansion and repopulation of empty or evacuated space by hematopoietic stem cells (HSCs). Although the patient experiences an early loss of bone marrow myeloid-derived cells, stem cell expansion is largely skewed towards the repopulation of the myeloid lineage/compartment. The hypothesis is that this 'emergency myelopoiesis' is critical for the survival of the severely traumatized and further, failure of the emergency myelopoietic response is associated with global immunosuppression and susceptibility to secondary infection. Also, identifying the release of myeloid derived suppressor cells (MDSCs) in the circulation of human severe trauma subjects. This process is driven by HSCs in the bone marrow of trauma subjects. Additionally, MDSCs may have a profound effect on the nutritional status of the host. The appearance of these MDSCs after trauma is associated with a loss of muscle tissue in these subjects. This muscle loss and possible increased catabolism have huge effects on long term outcomes for these subjects. It is the investigator's goal to understand the differences that occur in these in HSCs and muscle cells as opposed to non-injured and non-infected controls. This work will lead to a better understanding of the myelopoietic and catabolic response following trauma.

CONDITIONS

Official Title

Hematopoietic Stem Cell Dysfunction in the Elderly After Severe Injury

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 54 years with blunt or penetrating trauma causing long bone or pelvic fractures requiring surgery or pinning
  • Trauma patients aged 18 to 54 years with hemorrhagic shock (systolic blood pressure ≤ 90 mmHg, mean arterial pressure ≤ 65 mmHg, base deficit ≥ 5 meq, or lactate ≥ 2) or injury severity score ≥ 15
  • Adults aged 55 years and older with blunt or penetrating trauma resulting in long bone or pelvic fractures requiring surgery or pinning
  • Trauma patients aged 55 years and older with hemorrhagic shock (systolic blood pressure ≤ 90 mmHg, mean arterial pressure ≤ 65 mmHg, base deficit ≥ 5 meq, or lactate ≥ 2) or injury severity score ≥ 15
  • Adults aged 18 years and older undergoing elective hip repair for non-infectious reasons
  • Ability to provide informed consent before surgery
Not Eligible

You will not qualify if you...

  • Patients not expected to survive more than 48 hours
  • Prisoners
  • Pregnant individuals
  • Patients receiving chronic corticosteroids or immunosuppressive therapies
  • History of bone marrow transplantation
  • Patients with end-stage renal disease
  • Patients with any pre-existing hematological disease
  • History of chemotherapy or radiation within the last 6 months for elective hip repair group

AI-Screening

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Trial Site Locations

Total: 1 location

1

UF Health Shands Hospital at the University of Florida

Gainesville, Florida, United States, 32610

Actively Recruiting

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Research Team

J

Jennifer D Lanz, MSN

CONTACT

R

Ruth J Davis, ASN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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Hematopoietic Stem Cell Dysfunction in the Elderly After Severe Injury | DecenTrialz