RECRUITING

Pathological Myeloid Activation After Sepsis and Trauma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this observational study is to better understand what happens to circulating blood after a patient experiences severe trauma injury. The main questions it aims to answer are: Is severe human trauma associated with specific patterns of development in the hematopoietic stem cells of these patients? and Does the initial severe trauma injury create immunosuppression and increase risk of in-hospital sepsis? Participants in study will give blood samples and a waste sample of bone marrow at time of operative repair of traumatic orthopedic injuries, supply medical information and participate in surveys and assessments during recovery from their injury(ies). Researchers will compare severe trauma injury patients to elective hip repair patients to see if immunosuppression and specific development patterns occur in the trauma patient versus the otherwise healthy hip surgery patient.

Official Title

Pathological Myeloid Activation After Sepsis and Trauma Subtitle: Dysfunctional Myelopoiesis and Myeloid-Derived Suppressor Cells in Sepsis Pathobiology

Quick Facts

Study Start:2022-09-01
Study Completion:2028-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05616130

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. All adults age ≥ 18 years
  2. 2. Blunt and/or penetrating trauma resulting in long bone or pelvic fractures requiring open reduction internal fixation or closed reduction percutaneous pinning
  3. 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)
  1. 1. Patients not expected to survive greater than 48 hours.
  2. 2. Prisoners.
  3. 3. Pregnancy.
  4. 4. Patients receiving chronic corticosteroids or immunosuppression therapies.
  5. 5. Previous bone marrow transplantation.
  6. 6. Patients with End Stage Renal Disease.
  7. 7. Patients with any pre-existing hematological disease.
  8. 8. Patients deemed to be futile care or have advanced directives limiting resuscitative efforts.
  9. 9. Patients with severe congestive heart failure (NY Heart Association Class IV).
  10. 10. Known HIV infection with CD4+ (clusters of differentiation) count \<200 cells/mm3
  11. 11. Chronic liver disease with MELD (Model for End-Stage Liver Disease) score ≥15

Contacts and Locations

Study Contact

Ruth Davis, BSN
CONTACT
352-273-8759
ruth.davis@surgery.ufl.edu
Jennifer Lanz, MSN
CONTACT
352-273-5497
jennifer.lanz@surgery.ufl.edu

Principal Investigator

Philip Efron, MD
PRINCIPAL_INVESTIGATOR
UF COM Department of Surgery

Study Locations (Sites)

UF Health at Shands Hospital
Gainesville, Florida, 32610
United States

Collaborators and Investigators

Sponsor: University of Florida

  • Philip Efron, MD, PRINCIPAL_INVESTIGATOR, UF COM Department of Surgery

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-01
Study Completion Date2028-09-30

Study Record Updates

Study Start Date2022-09-01
Study Completion Date2028-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Trauma Injury
  • Sepsis
  • Immunosuppression
  • Chronic Critical Illness