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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT06314841
Other study ID # LBG-AUVA
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date June 1, 2017
Est. completion date January 1, 2022

Study information

Verified date July 2018
Source Ludwig Boltzmann Gesellschaft
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 62
Est. completion date January 1, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
Austria Ludwig Boltzmann Institute for Experimental and Clinical Traumatology, AUVA Trauma Research Center Vienna
Austria Trauma Center Vienna, Lorenz Böhler Vienna
Austria Trauma Center Vienna, Meidling Vienna

Sponsors (2)

Lead Sponsor Collaborator
Ludwig Boltzmann Gesellschaft AUVA

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Immunocompetence Infection during observation period 30 days after admission to ER
Secondary 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
Secondary 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
Secondary 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
Secondary Immunocompetence clusters Clustering of patient immunocompetence characteristics by artificial intelligence 30 days after admission to ER
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