Serious ConditionPRIUSNCT03089359
Prehospital Recognition and Identification of Unspecific Symptoms
An observational study of Serious Condition and Morality, run by Karolinska Institutet at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Serious Condition, Morality
- How many people
- 414 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 4 May 2015to 23 Mar 2021
- 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
- Adult, Older adult
Study population: Unspecific symptoms presenting to the EMS
Who may be able to join
- 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
Who cannot join
- Specific symptoms
- under 18 years of age
- Stays home / other caregiver than ED
- Referral from caregiver
- No personal numer (social security number)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
- Conditions
- Serious Condition, Morality
- Keywords
- Unspecific symptoms, Soluvent urokinase plasminogen activator receptor, Lactate, Emergency Medical Services
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious condition
Predefined serious condition
Measured: During medical care event
Secondary outcomes (1)
Mortality
24h and 30 day mortality
Measured: 24hours and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start4 May 2015
- Primary completion23 Mar 2021
- Study completion23 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Serious ConditionStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- 414 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katarina Bohm, Karolinska Institutet
- Investigators
- Katarina Bohm, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089359
- Sponsor's protocol ID
- PRIUS
- Acronym
- PRIUS
- Status last verified
- Mar 2021
- First submitted
- 20 Mar 2017
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34384460
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehospital Recognition and Identification of Unspecific Symptoms
- ClinicalTrials.gov ID
- NCT03089359
- Acronym / sponsor ID
- PRIUS / PRIUS
- Conditions
- Serious Condition, Morality
- Keywords
- Unspecific symptoms, Soluvent urokinase plasminogen activator receptor, Lactate, Emergency Medical Services
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 414 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 4 May 2015 (actual)
- Primary completion
- 23 Mar 2021 (actual)
- Study completion
- 23 Mar 2021 (actual)
- First posted
- 24 Mar 2017 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Unspecific symptoms presenting to the EMS
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Specific symptoms
- under 18 years of age
- Stays home / other caregiver than ED
- Referral from caregiver
- No personal numer (social security number)
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
Serious condition
Time frame: During medical care event
Predefined serious condition
1 secondary outcome
Mortality
Time frame: 24hours and 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Derived from this study: PubMed 34384460Ivic 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.
- Individual participant dataSharing planned: No
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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.
Katarina Bohm, PhD principal investigator
Karolinska Institutet
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Serious Condition and Morality, run by Karolinska Institutet at 2 sites in 2 countries.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland, Sweden. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Serious condition (time frame: During medical care event). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03089359, which also lists 1 linked publication.
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 25 Mar 2021.