Wounds and InjuriesPRIMENCT06314841
Polytrauma and Resuscitation Impact on Innate Immunity
An observational study of Wounds and Injuries, run by Ludwig Boltzmann Gesellschaft at 3 sites in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds and Injuries
- How many people
- 62 participants
- Where
- 3 sitesAustria
- Study dates
- 1 Jun 2017to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age > 18
- Injury Severity Score (ISS) > 15
- Incident to admission time < 3h
Who cannot join
- Preexisting condition
- Pregnancy or breastfeeding
- Diabetes
- Coronary Heart Disease
- Intake of antiphlogistic medication
- Neoplasm
Trial locations and contacts
3 sites in 1 country.
Austria3 sites
Trauma Center Vienna, Meidling
Vienna, 1120
Ludwig Boltzmann Institute for Experimental and Clinical Traumatology, AUVA Trauma Research Center
Vienna, 1200
Trauma Center Vienna, Lorenz Böhler
Vienna, 1200
About this study
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.
Read the 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.
- Conditions
- Wounds and Injuries
- Medical subject headings
- Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunocompetence
Infection during observation period
Measured: 30 days after admission to ER
Secondary outcomes (4)
Changes in cellular immuno-status
Flow cytometric assessment of leukocyte subsets and the expression of surface molecules involved in antigen presentation and immuno-suppression.
Measured: 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.
Measured: 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.
Measured: 0 hours, 24 hours after admission to ER
Immunocompetence clusters
Clustering of patient immunocompetence characteristics by artificial intelligence
Measured: 30 days after admission to ER
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 Jun 2017
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Why it stopped: Recruitment could not be resumed due to the COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig Boltzmann Gesellschaft
- Sponsor type
- University, hospital or other
- Collaborators
- AUVA
- Responsible party
- Principal investigator, Gerhard Fritsch, Ludwig Boltzmann Gesellschaft
- Investigators
- Susanne Drechsler, DVM, Study chair, Ludwig Boltzmann Institute for Experimental and Clinical TraumatologyMarcin Osuchowski, DVM, Study chair, Ludwig Boltzmann Institute for Experimental and Clinical TraumatologyHeinz Steltzer, MD, Prof., Study chair, Trauma Center Vienna, Meidling
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314841
- Sponsor's protocol ID
- LBG-AUVA
- Acronym
- PRIME
- Status last verified
- Jul 2018
- First submitted
- 30 Jul 2018
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polytrauma and Resuscitation Impact on Innate Immunity
- ClinicalTrials.gov ID
- NCT06314841
- Acronym / sponsor ID
- PRIME / LBG-AUVA
- Conditions
- Wounds and Injuries
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment could not be resumed due to the COVID-19 pandemic
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Ludwig Boltzmann GesellschaftUniversity, hospital or other
- Collaborators
- AUVA
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age > 18
- Injury Severity Score (ISS) > 15
- Incident to admission time < 3h
Key exclusion criteria (6 listed)
- Preexisting condition
- Pregnancy or breastfeeding
- Diabetes
- Coronary Heart Disease
- Intake of antiphlogistic medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Immunocompetence
Time frame: 30 days after admission to ER
Infection during observation period
4 secondary outcomes
Changes in cellular immuno-status
Time frame: 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
Platelet-leukocyte aggregates
Time frame: 0 hours, 24 hours after admission to ER
Immunocompetence clusters
Time frame: 30 days after admission to ER
Results and safety
The study was stopped early (reason given: Recruitment could not be resumed due to the COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
Related trials for Wounds and Injuries
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
Recruiting
Implant for Walking After Incomplete SCI
Spinal Cord Injury (SCI), Gait
Recruiting
Lateral Ankle Treatment
Avulsion Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
Enrolling by invitationObservational study
Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials
Traumatic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne Drechsler, DVM study chair
Ludwig Boltzmann Institute for Experimental and Clinical Traumatology
Marcin Osuchowski, DVM study chair
Ludwig Boltzmann Institute for Experimental and Clinical Traumatology
Heinz Steltzer, MD, Prof. study chair
Trauma Center Vienna, Meidling
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wounds and Injuries, run by Ludwig Boltzmann Gesellschaft at 3 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment could not be resumed due to the COVID-19 pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunocompetence (time frame: 30 days after admission to ER). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.