Hematopoietic Stem Cell Dysfunction in the Elderly After Severe Injury

Launched by UNIVERSITY OF FLORIDA · Oct 13, 2015

Keywords

ClinConnect Summary

This clinical trial is studying how severe injuries affect the bone marrow and immune system in older adults. Researchers believe that after a serious injury, the body quickly tries to replace lost blood cells, which is essential for survival. However, this response can sometimes fail, leading to a weakened immune system and a higher risk of infections. The trial aims to learn more about these changes in the bone marrow and how they might relate to muscle loss and overall recovery after trauma.

To participate, you need to be an adult aged 18 or older who has experienced a serious injury, such as fractures from blunt or penetrating trauma. If you are 55 or older, you will also need to have specific types of injury and signs of significant blood loss. Participants will help researchers understand the body's reactions to severe injuries and how these might affect long-term health. It’s important to note that certain individuals, such as those with previous bone marrow issues or severe kidney disease, may not be eligible for the study. If you qualify, you will be asked to provide informed consent before any procedures are performed.

Gender

ALL

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