Clinical trial NCT06314841: Polytrauma and Resuscitation Impact on Innate Immunity
Official title: Polytrauma and Resuscitation Impact on Innate Immunity
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Wounds and Injuries
Lead sponsor: Ludwig Boltzmann Gesellschaft
Sponsor class: OTHER
Collaborators: name: AUVA
First posted: 2024-03-18
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Polytraumatized patients older than 18 years, that were directly (within 3 hours) admitted to the emergency room of one the participating trauma centers and that do not match one of the exclusion criteria.

Brief summary: Major trauma can lead to a dysregulated response to secondary infection. Severe injuries are accompanied by pro- and antiinflammatory changes that affect both adaptive and innate immunity. In this study we aim to assess cellular immuno-competence early during treatment in an attempt to identify signs of immuno-suppression.

Detailed description: Polytrauma represents one of the most challenging critical conditions for caretakers worldwide and involves multiple damages of different anatomical regions. Severe traumatic injuries are among the primary causes of death among young people under the age of 45 and half of them are due to uncontrollable bleeding. In the acute injury phase of trauma, severe blood loss is often accompanied by biochemical, cellular and physiological dysfunctions leading to an inflammatory response, infections and in some cases coagulopathy. We aim to identify immuno-suppression by analyzing phagocytic capacity, leukocyte subsets, surface molecule expression and extracellular vesicles in the peripheral blood of severly injured patients.

Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Injury Severity Score (ISS) \> 15
* Incident to admission time \< 3h

Exclusion Criteria:

* Preexisting condition
* Pregnancy or breastfeeding
* Diabetes
* Coronary Heart Disease
* Intake of antiphlogistic medication
* Neoplasm

Primary outcomes:
measure: Immunocompetence
timeFrame: 30 days after admission to ER
Secondary outcomes:
measure: Changes in cellular immuno-status
timeFrame: 0 hours, 24 hours, 48 hours, 96 hours after admission to ER
measure: Release of extracellular vesicles and associated content
timeFrame: 0 hours, 24 hours after admission to ER
measure: Platelet-leukocyte aggregates
timeFrame: 0 hours, 24 hours after admission to ER
measure: Immunocompetence clusters
timeFrame: 30 days after admission to ER
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Trauma Center Vienna, Meidling
city: Vienna
country: Austria
facility: Ludwig Boltzmann Institute for Experimental and Clinical Traumatology, AUVA Trauma Research Center
city: Vienna
country: Austria
facility: Trauma Center Vienna, Lorenz Böhler
Study officials:
affiliation: Ludwig Boltzmann Institute for Experimental and Clinical Traumatology
name: Susanne Drechsler, DVM
role: STUDY_CHAIR
affiliation: Ludwig Boltzmann Institute for Experimental and Clinical Traumatology
name: Marcin Osuchowski, DVM
role: STUDY_CHAIR
affiliation: Trauma Center Vienna, Meidling
name: Heinz Steltzer, MD, Prof.
role: STUDY_CHAIR
References: