Pathological Myeloid Activation After Sepsis and Trauma

Launched by UNIVERSITY OF FLORIDA · Nov 7, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how severe trauma injuries, like serious fractures from accidents, affect the blood and immune system of patients. Researchers want to find out if these injuries lead to changes in blood-producing cells and if they make patients more vulnerable to infections while in the hospital. To do this, they will collect blood and bone marrow samples from participants who have experienced severe trauma and compare them with those undergoing routine hip repair surgeries to see if there are differences in immune responses.

To be eligible for this study, participants must be adults aged 18 or older who have suffered significant injuries requiring specific medical treatments. Those with certain serious health issues or who are not expected to survive for more than 48 hours will not be included. Participants will need to provide medical information and take part in surveys during their recovery. This study is currently recruiting, and it aims to help improve understanding of the effects of trauma on the body, which could lead to better care for patients in the future.

Gender

ALL

Eligibility criteria

• • Trauma population
• Inclusion Criteria:
• • 1. All adults age ≥ 18 years
• • 2. Blunt and/or penetrating trauma resulting in long bone or pelvic fractures requiring open reduction internal fixation or closed reduction percutaneous pinning
• • 3. Blunt and/or penetrating trauma patient with a. Injury Severity Score (ISS) greater than or equal to 25 b. ISS \> 15 and one of the following: i. \> 4 units of packed red blood cell or \>3 units of whole blood or \>1500 ml of autogenous blood product in the first 24 hours of admission ii. AIS (acute injury score) \> 2 spine iii. Shock on arrival (SBP \< 90)
• • OR
• • c. ISS \> 15 and two of the following: i. Age \> 55 ii. AIS \> 2 chest iii. +ethyl alcohol on arrival iv. Any red blood cell transfusion in first 24 hours
• Exclusion Criteria:
• • 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.
• • 8. Patients deemed to be futile care or have advanced directives limiting resuscitative efforts.
• • 9. Patients with severe congestive heart failure (NY Heart Association Class IV).
• • 10. Known HIV infection with CD4+ (clusters of differentiation) count \<200 cells/mm3
• • 11. Chronic liver disease with MELD (Model for End-Stage Liver Disease) score ≥15
• • Elective Hip population
• Inclusion Criteria:
• • 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:
• • 1. Pregnancy.
• • 2. Prisoners.
• • 3. Patients receiving chronic corticosteroids or immunosuppression therapies.
• • 4. Pre-existing conditions such as pathological fractures, cancer, history of HIV, or history of connective tissue disease.
• • 5. Previous bone marrow transplantation.
• • 6. Patients with End Stage Renal Disease.
• • 7. Patients with any pre-existing hematological disease.
• • 8. Patients with known active/symptomatic COVID-19 (Coronavirus disease).