NCT02577731 Hematopoietic Stem Cell Dysfunction in the Elderly After Severe Injury
| NCT ID | NCT02577731 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Florida |
| Condition | Trauma Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2014-01 |
| Primary Completion | 2026-12-28 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2014-01 with a primary completion date of 2026-12-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Philip Efron, MD
PRINCIPAL INVESTIGATOR
University of Florida
Frequently Asked Questions
Who can join the NCT02577731 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Trauma Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02577731 currently recruiting?
Yes, NCT02577731 is actively recruiting participants. Contact the research team at jennifer.lanz@surgery.ufl.edu for enrollment information.
Where is the NCT02577731 trial being conducted?
This trial is being conducted at Gainesville, United States.
Who is sponsoring the NCT02577731 clinical trial?
NCT02577731 is sponsored by University of Florida. The principal investigator is Philip Efron, MD at University of Florida. The trial plans to enroll 400 participants.