Polytrauma and Resuscitation Impact on Innate Immunity (PRIME)

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.

Study Overview

• Status: Terminated
• Conditions: Wounds and Injuries

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 Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1120
    • Trauma Center Vienna, Meidling
  • Vienna, Austria, 1200
    • Ludwig Boltzmann Institute for Experimental and Clinical Traumatology, AUVA Trauma Research Center
  • Vienna, Austria, 1200
    • Trauma Center Vienna, Lorenz Böhler

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunocompetence	Infection during observation period	30 days after admission to ER

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ludwig Boltzmann Gesellschaft
• Collaborators: AUVA
• Investigators: Study Chair: Susanne Drechsler, DVM, Ludwig Boltzmann Institute for Experimental and Clinical Traumatology; Study Chair: Marcin Osuchowski, DVM, Ludwig Boltzmann Institute for Experimental and Clinical Traumatology; Study Chair: Heinz Steltzer, MD, Prof., Trauma Center Vienna, Meidling

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: July 30, 2018
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Multiple Trauma
• Other Study ID Numbers: LBG-AUVA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No