Polytrauma and Resuscitation Impact on Innate Immunity

Wounds and Injuries Clinical Trial

— PRIME  

Official title:

Polytrauma and Resuscitation Impact on Innate Immunity

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT06314841
• Other study ID #: LBG-AUVA
• Status: Terminated
• 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
• 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

Related Conditions & MeSH terms

• Multiple Trauma
• Wounds and Injuries

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