Prehospital Recognition and Identification of Unspecific... | NCT03089359

Studies
Prehospital Recognition and Identification of Unspecific Symptoms

NCT03089359

Sponsor

Karolinska Institutet

Status

Completed

Last Update Posted

Mar 25, 2021Actual

Enrollment

414Actual

Phase

Not provided

Conditions

Serious Condition
Morality

Interventions

Not provided

Countries

Finland
Sweden

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

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 4, 2015Actual

Primary Completion Date

Mar 23, 2021Actual

Completion Date

Mar 23, 2021Actual

First Submitted Date

Mar 20, 2017

First Submission Date that Met QC Criteria

Mar 20, 2017

First Posted Date

Mar 24, 2017Actual

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 24, 2021

Last Update Posted Date

Mar 25, 2021Actual

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

This study evaluates the predictive value of soluvent urokinase plasminogen activator receptor (suPAR) and lactate with respect to serious conditions among patients presenting to the EMS with unspecific symptoms.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

414Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serious condition	Predefined serious condition	During medical care event

Secondary Outcomes

Measure	Description	Time Frame
Mortality	24h and 30 day mortality	24hours and 30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Unspecific symptoms (not feeling well, decreased general health condition, unable to cope with usual daily activities, feeling weak)
Normal vital signs
Transported to ED
Able to give informed consent/ Next of kin gives informed consent

Exclusion Criteria:

Specific symptoms
under 18 years of age
Stays home / other caregiver than ED
Referral from caregiver
No personal numer (social security number)

Accepts Healthy Volunteers

Not provided

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

Unspecific symptoms presenting to the EMS

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Katarina Bohm, PhD	Karolinska Institutet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki University		Helsinki		00029	Finland
Karolinska Institute

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34384460	Derived	Ivic R, Nurmi J, Kurland L, Vicente V, Lindstrom V, Djarv T, Kaartinen J, Castren M, Bohm K. Soluble urokinase plasminogen activator receptor and lactate as prognostic biomarkers in patients presenting with non-specific chief complaints in the pre-hospital setting - the PRIUS-study. Scand J Trauma Resusc Emerg Med. 2021 Aug 12;29(1):116. doi: 10.1186/s13049-021-00908-z.