Pathological Myeloid Activation After Sepsis and Trauma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorUniversity of Florida
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All adults age ≥ 18 years
Blunt and/or penetrating trauma resulting in long bone or pelvic fractures requiring open reduction internal fixation or closed reduction percutaneous pinning
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)
Disqualifiers
Patients not expected to survive greater than 48 hours.
Prisoners.
Pregnancy.
Patients receiving chronic corticosteroids or immunosuppression therapies.
Trial population
Patients admitted to surgical and trauma intensive care units who have suffered severe trauma with major orthopedic injury requiring open reduction and internal fixation of the broken bone. Patients seeking an elective hip repair at the UF Orthopedic Sports Medicine Institute.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Data Collection
Other interventionResearcher will collect data from subject's medical records: information regarding your medical history, trauma injury, heart rate, blood pressure, temperature (vital signs), use of antibiotics (medications used to treat infection) and other medications, development of infection, and treatment results will be recorded and kept with your research records. Demographic information (such as name, address, phone number, gender, race, height and weight, age and birth date), medical record notes (including but not limited to history and physical exam notes, progress notes, consultation reports, laboratory test results, operative reports, information relating to acquired immunodeficiency virus (HIV) infection, radiologic (x-ray studies) results, and blood samples)
Bone marrow collection and blood collection
Procedure/SurgeryAt time of scheduled surgery, researcher will collect a 20ml (approximately 4 teaspoons) sample of bone marrow while you are in the operating room receiving surgery for your orthopedic (bone) injuries or elective hip repair. Blood collection will occur at time of surgery, day 14 on study or discharge from hospital and at 3 and 6 months. Up to 58 ml (about 4 tablespoons) sample of blood will be collected from an existing intravenous line or peripheral needle stick.
Serial interviews to complete surveys and questionnaires
Other interventionParticipants will be asked to complete questionnaires and surveys that assess your health, quality of life, daily living activities, and mobility. These activities occur at enrollment, day 14 in hospital or discharge, and at the 3, 6, and 12-month visits.
Telephone follow up call
Other interventionThe study team will contact you at 12 months to complete a telephone interview to learn about your health and well being.
Treatment groups
255 Participants
are divided into 2 treatment groupsGroup A: Trauma4 interventions
Group B: Elective Hip Repair4 interventions
Trial outcomes
Primary outcomes
1
Test hypothesis that response to initial stimulus (trauma) is associated with a high risk of inhospital sepsis, the bone marrow (BM) hematopoietic stem and progenitor cells (HSPCs) promote immunosuppressive myelopoiesis at the expense of lymphopoiesis.
With subsequent sepsis development, MDSCs induce their continued expansion through exocrine and paracrine signaling to HSPCs. HSPCs and MDSCs derived from severe blunt trauma patients will be analyzed for epigenetic (MAPit DNA methylation) and functional changes (ability to generate colony forming units (CFUs)) that initiate sepsis and continue the expansion of immunosuppressive MDSCs.
Time frame
Through study completion, an average of 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Florida
Lead sponsor
National Institute of General Medical Sciences (NIGMS)
Collaborator
Source ClinicalTrials.gov