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Hematopoietic Stem Cell Dysfunction in the Elderly After Severe Injury

RecruitingNAAges 18 Years - anyAllUniversity of Florida
NCT02577731 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 myelopoi

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📋 Eligibility rules (as published)
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
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What it tests

  • Bone marrow collection
  • Blood collection
  • Clinical data collection
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Where

1 site
UF Health Shands Hospital at the University of Florida
Gainesville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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