Polytrauma and Resuscitation Impact on Innate Immunity

Terminated

• Conditions: Wounds and Injuries

• Registration Number: NCT06314841
• Lead Sponsor: Ludwig Boltzmann Gesellschaft

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.

Study Timeline

• Study Start: 2017-06-01
• Status Verified: 2018-07
• Study First Submitted: 2018-07-30
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01
• Study First Submitted QC: 2024-03-13
• Last Update Submitted: 2024-03-13
• Study First Posted: 2024-03-18
• Last Update Posted: 2024-03-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunocompetence	30 days after admission to ER	Infection during observation period

Secondary Outcome Measures

Name	Time	Method
Changes in cellular immuno-status	0 hours, 24 hours, 48 hours, 96 hours after admission to ER	Flow cytometric assessment of leukocyte subsets and the expression of surface molecules involved in antigen presentation and immuno-suppression.
Release of extracellular vesicles and associated content	0 hours, 24 hours after admission to ER	Flow cytometric assessment of the release of extracellular vesicles from various cell types.
Platelet-leukocyte aggregates	0 hours, 24 hours after admission to ER	Formation of platelet-leukocyte aggregates in the peripheral blood upon admission and on the ICU.
Immunocompetence clusters	30 days after admission to ER	Clustering of patient immunocompetence characteristics by artificial intelligence

Trial Locations

Locations (3)

Trauma Center Vienna, Meidling; 🇦🇹 Vienna, Austria

Ludwig Boltzmann Institute for Experimental and Clinical Traumatology, AUVA Trauma Research Center; 🇦🇹 Vienna, Austria

Trauma Center Vienna, Lorenz Böhler; 🇦🇹 Vienna, Austria