Recruiting

Observational Study

Sponsor:

University of Florida

Code:

NCT02577731

Conditions

Trauma Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bone marrow collection

Blood collection

Clinical data collection

Study Details

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.

Conditions

Trauma Injury

Study ID

NCT02577731

Start date

Jan, 2014

Status verified date

Apr, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Severe Trauma

Bone marrow collection. Blood collection. Clinical data collection.

other: Elective Hip Repair

Bone marrow collection. Blood collection. Clinical data collection.

other: Healthy Young Bone Marrow Control

Deidentified freshly isolated bone marrow samples from healthy young control subjects will be purchased for a tissue bank.

Interventions

Bone marrow collection

Bone marrow will be collected from the patient at time of orthopedic repair in the operating room. A second sample may be collected if the patient is required to return to the operating room for further repair of orthopedic injury.

Blood collection

Blood sample collection will be collected from the patient at time of orthopedic repair in the operating room. A second sample may be collected if the patient is required to return to the operating room for further repair of orthopedic injury.

Clinical data collection

Clinical data collection will encompass demographic information, past and present medical records, laboratory, microbiology, and all other test results, x-ray, CT, MRI, US and all other imaging test results, records about any medication received during admission, records of physical exam during admission, records of all vital signs and hemodynamic monitoring during admission, records of any procedure or intervention during admission, records of any procedure or intervention during hospital admission, condition at the discharge and discharge facility.

Primary outcome measure

  • Analyze the genomics response of hematopoietic cells between the groups [ Time Frame: Baseline ]
  • Analyze the muscle dysfunction between the groups for oxidative stress [ Time Frame: Baseline ]
  • Analyze the muscle dysfunction between the groups for mitochondrial activity [ Time Frame: Baseline ]
  • Analyze the muscle dysfunction between the groups for apoptosis [ Time Frame: Baseline ]
  • Analyze the muscle dysfunction between the groups for autophagy [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Jennifer D Lanz, MSN

352-273-5497jennifer.lanz@surgery.ufl.edu

Ruth J Davis, ASN

352-273-8759ruth.davis@surgery.ufl.edu

Locations

UF Health Shands Hospital at the University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Jennifer Lanz, MSN

352-273-5497jennifer.lanz@surgery.ufl.edu

Ruth Davis, ASN

352-273-8759ruth.davis@surgery.ufl.edu

Principal Investigator:

Philip Efron, MD

More Information

Sponsor

University of Florida

Last update posted

Jan 15, 2026

Last verified

Apr, 2025

Keywords

  • Trauma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-01-15.