Trauma's hidden toll: new study probes blood changes that raise infection risk
NCT ID NCT05616130
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at what happens to blood and bone marrow after a severe injury. Researchers want to understand why some trauma patients develop a weakened immune system and get serious infections like sepsis. About 255 adults with severe fractures will give blood and a small bone marrow sample during surgery. Their results will be compared to people having routine hip surgery. No new treatment is being tested — the goal is simply to learn more.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 255 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2022
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 to 100 years
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UF Health at Shands Hospital
RECRUITINGGainesville, Florida, 32610, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a computer model speed up sepsis blood tests?
- Can a brainstem reflex score better predict which trauma patients will die?
- Stem cells put to the test against Sepsis's immune chaos
- Can the immune system reveal who will suffer kidney injury after sepsis?