Polytrauma and Resuscitation Impact on Innate Immunity | NCT06314841

Studies
Polytrauma and Resuscitation Impact on Innate Immunity

NCT06314841

Sponsor

Ludwig Boltzmann Gesellschaft

Status

Terminated

Last Update Posted

Mar 18, 2024Actual

Enrollment

62Actual

Phase

Not provided

Conditions

Wounds and Injuries

Interventions

Not provided

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitment could not be resumed due to the COVID-19 pandemic

Expanded Access Info

Start Date

Jun 1, 2017Actual

Primary Completion Date

Jan 1, 2022Actual

Completion Date

Jan 1, 2022Actual

First Submitted Date

Jul 30, 2018

First Submission Date that Met QC Criteria

Mar 13, 2024

First Posted Date

Mar 18, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2024

Last Update Posted Date

Mar 18, 2024Actual

Name	Class
AUVA	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

62Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Immunocompetence	Infection during observation period	30 days after admission to ER

Secondary Outcomes

Measure	Description	Time Frame
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
Release of extracellular vesicles and associated content

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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 Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Trauma Center Vienna, Meidling		Vienna		1120	Austria
Ludwig Boltzmann Institute for Experimental and Clinical Traumatology, AUVA Trauma Research Center

Condition Browse Module

MeSH Terms

ID	Term
D014947	Wounds and Injuries

Ancestor Terms

Not provided

Browse Leaves

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Browse Branches

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