Study Stopped
Recruitment could not be resumed due to the COVID-19 pandemic
Polytrauma and Resuscitation Impact on Innate Immunity
PRIME
1 other identifier
observational
62
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2017
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedFirst Posted
Study publicly available on registry
March 18, 2024
CompletedMarch 18, 2024
July 1, 2018
4.6 years
July 30, 2018
March 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Immunocompetence
Infection during observation period
30 days after admission to ER
Secondary Outcomes (4)
Changes in cellular immuno-status
0 hours, 24 hours, 48 hours, 96 hours after admission to ER
Release of extracellular vesicles and associated content
0 hours, 24 hours after admission to ER
Platelet-leukocyte aggregates
0 hours, 24 hours after admission to ER
Immunocompetence clusters
30 days after admission to ER
Eligibility Criteria
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.
You may qualify if:
- Age \> 18
- Injury Severity Score (ISS) \> 15
- Incident to admission time \< 3h
You may not qualify if:
- Preexisting condition
- Pregnancy or breastfeeding
- Diabetes
- Coronary Heart Disease
- Intake of antiphlogistic medication
- Neoplasm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ludwig Boltzmann Gesellschaftlead
- AUVAcollaborator
Study Sites (3)
Trauma Center Vienna, Meidling
Vienna, 1120, Austria
Ludwig Boltzmann Institute for Experimental and Clinical Traumatology, AUVA Trauma Research Center
Vienna, 1200, Austria
Trauma Center Vienna, Lorenz Böhler
Vienna, 1200, Austria
Biospecimen
Peripheral whole blood. Anticoagulants: Sodium-citrate, EDTA, Heparin. Retention of plasma samples.
MeSH Terms
Conditions
Study Officials
- 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 Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Priv.-Doz., Prim., Dr.med.univ
Study Record Dates
First Submitted
July 30, 2018
First Posted
March 18, 2024
Study Start
June 1, 2017
Primary Completion
January 1, 2022
Study Completion
January 1, 2022
Last Updated
March 18, 2024
Record last verified: 2018-07