Polytrauma and Resuscitation Impact on Innate Immunity (PRIME)

March 13, 2024 updated by: Gerhard Fritsch, Ludwig Boltzmann Gesellschaft
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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Immunocompetence
Time Frame: 30 days after admission to ER
Infection during observation period
30 days after admission to ER

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in cellular immuno-status
Time Frame: 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.
0 hours, 24 hours, 48 hours, 96 hours after admission to ER
Release of extracellular vesicles and associated content
Time Frame: 0 hours, 24 hours after admission to ER
Flow cytometric assessment of the release of extracellular vesicles from various cell types.
0 hours, 24 hours after admission to ER
Platelet-leukocyte aggregates
Time Frame: 0 hours, 24 hours after admission to ER
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
Time Frame: 30 days after admission to ER
Clustering of patient immunocompetence characteristics by artificial intelligence
30 days after admission to ER

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ludwig Boltzmann Gesellschaft

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
AUVA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Wounds and Injuries

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings