TriagesuPARNCT02643459
Risk Stratification in Acute Care: The Meaning of suPAR Measurement in Triage
A study testing suPAR measurement in people with Triage and Risk Stratification With Biomarker, run by Herlev Hospital at 1 site in Denmark.
Trial summary
Will clinical outcome for patients be improved if triage in Acute wards and Emergency rooms is supplemented with a prognostic biomarker? Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Triage, Risk Stratification With Biomarker
- What is being tested?
- suPAR measurement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,000 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2016to 6 Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients presenting acutely to the Acute ward/Emergency department and have blood samples done which include both Hemoglobin, C reactive protein and Creatinine within 6 hours of registration within the study period. The study is carried out in 2 Hospitals in the Capital of Denmark.
Who cannot join
- Patients presenting in Pediatric, Gynecological or Obstetric units. Patients not being examined with blood samples.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Introduction of Soluble Urokinase Plasminogen Activating Receptor in Acute Care as a Prognostic Biomarker to Strengthen Risk Stratification of Acutely Admitted Patients
Will clinical outcome for patients be improved if triage in Acute wards and Emergency rooms is supplemented with a prognostic biomarker?
Read the detailed description
In a health care system where the general population is growing, more patients are living with chronic conditions and the hospitals are reducing beds and length of stay, it is crucial to perform safe and fast risk stratification of patients presenting in the Emergency departments. Risk stratification is currently performed with a combination of measurement of the vital signs and assessment of the primary complaint. The aim of the current study is to assess whether the supplement of biomarkers can improve the risk stratification in regard to mortality, readmissions and improve overall patient flow in the Emergency departments. Soluble urokinase plasminogen activating receptor (suPAR) is the soluble form of urokinase-type plasminogen activator receptor (uPAR). uPAR is present on various immunological active cells, as well as endothelia and smooth muscle cells. It is believed that suPAR mirrors the inflammatory response in patients. Previous studies have shown a strong association with mortality and severity of disease in a broad variety of conditions (infection, hepatic-, renal-, cardiac- and lung disease) as well as a possible marker of disease development in the general population. These abilities indicate that suPAR although unspecific would be ideal to identify patients at high- and at low-risk. The aim is to target interventions and limited clinical focus where it is most beneficial. In unselected patients suPAR is one of the strongest prognostic biomarker available to date.
It is not known whether information on prognosis in the Emergency department can be used to prevent death, serious complications or reduce admissions and readmissions.
The purpose of the current study is to examine if introduction of the biomarker suPAR and education of doctors in the meaning of suPAR levels and association to disease, can reduce mortality, admissions and readmission in patients referred to the emergency rooms.
- Conditions
- Triage, Risk Stratification With Biomarker
- Being tested
- suPAR measurement
- Keywords
- Triage, Risk stratification, Acute care, suPAR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suPAR measurementBehavioural
The biomarker suPAR will be measured on all patients included in the study. Before the study period the doctors will receive information on suPAR. We want to study if the information provided by suPAR is useful in emergency medicine. Interventions depends on the clinical issue, as suPAR is an unspecific marker of disease. Usually a elevated suPAR level could result in more investigation e.g. diagnostic procedures or follow up, while a low suPAR could result in faster discharge.
| Study group | Role | What they receive |
|---|---|---|
| Conventional | No intervention | no suPAR measurement. Standard care. |
| suPAR | Experimental | suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR. Since suPAR is measured on all patients regardless of disease the investigators cannot define a single intervention. A possible intervention depends on the clinical situation. Receives: Behavioral: suPAR measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
All Cause Mortality
Time frame starts at the beginning of the index admission, defined as first admission in the study period. Patients will be followed using central registers.
Measured: 10 months after the inclusions period ends mortality data will be assessed
Secondary outcomes (7)
All Cause Mortality
Mortality within 30 days
Measured: 1 months after index admission mortality data will assessed
Number of Discharges From the Emergency Room Within 24 Hours
How many patients are discharged directly from the ED
Measured: 24 hours
Number of Admissions to the Medical Ward
Number of Participants with Admissions to the Medical War
Measured: 30 days
Number of Patients With an Admission to the Intensive Care Unit
Number of Participants with transfer to the ICU
Measured: 30 days
Number of Patients With New Cancer Diagnosis in Control vs Intervention Groups
Measured: 10 months after inclusion period ends
Length of Stay During Admission.
Length of stay in days during the admission
Measured: 30 days
Number of Readmissions
Patients will be followed using central registers. All new admissions within 90 days of the same patient is defined as readmissions.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startJan 2016
- Primary completion6 Apr 2017
- Study completion6 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for TriageStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Schultz, Herlev Hospital
- Investigators
- Kasper K Iversen, MD, DMSci, Study director, Department of Cardiology, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643459
- Sponsor's protocol ID
- HerlevH01
- Acronym
- suPAR
- Status last verified
- Feb 2021
- First submitted
- 13 Nov 2015
- Last updated
- 9 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Schultz M, Rasmussen LJH, Hoi-Hansen T, Kjoller E, Jensen BN, Lind MN, Ravn L, Kallemose T, Lange T, Kober L, Rasmussen LS, Eugen-Olsen J, Iversen KK. Early Discharge from the Emergency Department Based on Soluble Urokinase Plasminogen Activator Receptor (suPAR) Levels: A TRIAGE III Substudy. Dis Markers. 2019 May 19;2019:3403549. doi: 10.1155/2019/3403549. eCollection 2019.
PubMed 31236143Schultz M, Rasmussen LJH, Kallemose T, Kjoller E, Lind MN, Ravn L, Lange T, Kober L, Rasmussen LS, Eugen-Olsen J, Iversen K. Availability of suPAR in emergency departments may improve risk stratification: a secondary analysis of the TRIAGE III trial. Scand J Trauma Resusc Emerg Med. 2019 Apr 11;27(1):43. doi: 10.1186/s13049-019-0621-7.
PubMed 30975178Schultz M, Rasmussen LJH, Andersen MH, Stefansson JS, Falkentoft AC, Alstrup M, Sando A, Holle SLK, Meyer J, Tornkvist PBS, Hoi-Hansen T, Kjoller E, Jensen BN, Lind M, Ravn L, Kallemose T, Lange T, Kober L, Rasmussen LS, Eugen-Olsen J, Iversen KK. Use of the prognostic biomarker suPAR in the emergency department improves risk stratification but has no effect on mortality: a cluster-randomized clinical trial (TRIAGE III). Scand J Trauma Resusc Emerg Med. 2018 Aug 28;26(1):69. doi: 10.1186/s13049-018-0539-5.
PubMed 30153859Sando A, Schultz M, Eugen-Olsen J, Rasmussen LS, Kober L, Kjoller E, Jensen BN, Ravn L, Lange T, Iversen K. Introduction of a prognostic biomarker to strengthen risk stratification of acutely admitted patients: rationale and design of the TRIAGE III cluster randomized interventional trial. Scand J Trauma Resusc Emerg Med. 2016 Aug 5;24:100. doi: 10.1186/s13049-016-0290-8.
PubMed 27491822
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introduction of Soluble Urokinase Plasminogen Activating Receptor in Acute Care as a Prognostic Biomarker to Strengthen Risk Stratification of Acutely Admitted Patients
- ClinicalTrials.gov ID
- NCT02643459
- Acronym / sponsor ID
- suPAR / HerlevH01
- Conditions
- Triage, Risk Stratification With Biomarker
- Keywords
- Triage, Risk stratification, Acute care, suPAR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20,000 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 6 Apr 2017 (actual)
- Study completion
- 6 Apr 2017 (actual)
- First posted
- 31 Dec 2015 (estimated)
- Results
- Posted 9 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Will clinical outcome for patients be improved if triage in Acute wards and Emergency rooms is supplemented with a prognostic biomarker?
Detailed description
In a health care system where the general population is growing, more patients are living with chronic conditions and the hospitals are reducing beds and length of stay, it is crucial to perform safe and fast risk stratification of patients presenting in the Emergency departments. Risk stratification is currently performed with a combination of measurement of the vital signs and assessment of the primary complaint. The aim of the current study is to assess whether the supplement of biomarkers can improve the risk stratification in regard to mortality, readmissions and improve overall patient flow in the Emergency departments. Soluble urokinase plasminogen activating receptor (suPAR) is the soluble form of urokinase-type plasminogen activator receptor (uPAR). uPAR is present on various immunological active cells, as well as endothelia and smooth muscle cells. It is believed that suPAR mirrors the inflammatory response in patients. Previous studies have shown a strong association with mortality and severity of disease in a broad variety of conditions (infection, hepatic-, renal-, cardiac- and lung disease) as well as a possible marker of disease development in the general population. These abilities indicate that suPAR although unspecific would be ideal to identify patients at high- and at low-risk. The aim is to target interventions and limited clinical focus where it is most beneficial. In unselected patients suPAR is one of the strongest prognostic biomarker available to date.
It is not known whether information on prognosis in the Emergency department can be used to prevent death, serious complications or reduce admissions and readmissions.
The purpose of the current study is to examine if introduction of the biomarker suPAR and education of doctors in the meaning of suPAR levels and association to disease, can reduce mortality, admissions and readmission in patients referred to the emergency rooms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional | No intervention | –no suPAR measurement. Standard care. |
| suPAR | Experimental | Behavioral: suPAR measurementsuPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR. Since suPAR is measured on all patients regardless of disease the investigators cannot define a single intervention. A possible intervention depends on the clinical situation. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients presenting acutely to the Acute ward/Emergency department and have blood samples done which include both Hemoglobin, C reactive protein and Creatinine within 6 hours of registration within the study period. The study is carried out in 2 Hospitals in the Capital of Denmark.
Key exclusion criteria (1 listed)
- Patients presenting in Pediatric, Gynecological or Obstetric units. Patients not being examined with blood samples.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| suPAR measurementThe biomarker suPAR will be measured on all patients included in the study. Before the study period the doctors will receive information on suPAR. We want to study if the information provided by suPAR is useful in emergency medicine. Interventions depends on the clinical issue, as suPAR is an unspecific marker of disease. Usually a elevated suPAR level could result in more investigation e.g. diagnostic procedures or follow up, while a low suPAR could result in faster discharge. | Behavioural | suPAR |
Primary outcome
All Cause Mortality
Time frame: 10 months after the inclusions period ends mortality data will be assessed
Time frame starts at the beginning of the index admission, defined as first admission in the study period. Patients will be followed using central registers.
7 secondary outcomes
All Cause Mortality
Time frame: 1 months after index admission mortality data will assessed
Number of Discharges From the Emergency Room Within 24 Hours
Time frame: 24 hours
Number of Admissions to the Medical Ward
Time frame: 30 days
Number of Patients With an Admission to the Intensive Care Unit
Time frame: 30 days
Number of Patients With New Cancer Diagnosis in Control vs Intervention Groups
Time frame: 10 months after inclusion period ends
Length of Stay During Admission.
Time frame: 30 days
Number of Readmissions
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31236143Schultz M, Rasmussen LJH, Hoi-Hansen T, Kjoller E, Jensen BN, Lind MN, Ravn L, Kallemose T, Lange T, Kober L, Rasmussen LS, Eugen-Olsen J, Iversen KK. Early Discharge from the Emergency Department Based on Soluble Urokinase Plasminogen Activator Receptor (suPAR) Levels: A TRIAGE III Substudy. Dis Markers. 2019 May 19;2019:3403549. doi: 10.1155/2019/3403549. eCollection 2019.
- Derived from this study: PubMed 30975178Schultz M, Rasmussen LJH, Kallemose T, Kjoller E, Lind MN, Ravn L, Lange T, Kober L, Rasmussen LS, Eugen-Olsen J, Iversen K. Availability of suPAR in emergency departments may improve risk stratification: a secondary analysis of the TRIAGE III trial. Scand J Trauma Resusc Emerg Med. 2019 Apr 11;27(1):43. doi: 10.1186/s13049-019-0621-7.
- Derived from this study: PubMed 30153859Schultz M, Rasmussen LJH, Andersen MH, Stefansson JS, Falkentoft AC, Alstrup M, Sando A, Holle SLK, Meyer J, Tornkvist PBS, Hoi-Hansen T, Kjoller E, Jensen BN, Lind M, Ravn L, Kallemose T, Lange T, Kober L, Rasmussen LS, Eugen-Olsen J, Iversen KK. Use of the prognostic biomarker suPAR in the emergency department improves risk stratification but has no effect on mortality: a cluster-randomized clinical trial (TRIAGE III). Scand J Trauma Resusc Emerg Med. 2018 Aug 28;26(1):69. doi: 10.1186/s13049-018-0539-5.
- Derived from this study: PubMed 27491822Sando A, Schultz M, Eugen-Olsen J, Rasmussen LS, Kober L, Kjoller E, Jensen BN, Ravn L, Lange T, Iversen K. Introduction of a prognostic biomarker to strengthen risk stratification of acutely admitted patients: rationale and design of the TRIAGE III cluster randomized interventional trial. Scand J Trauma Resusc Emerg Med. 2016 Aug 5;24:100. doi: 10.1186/s13049-016-0290-8.
- 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.
Kasper K Iversen, MD, DMSci study director
Department of Cardiology, Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing suPAR measurement in people with Triage and Risk Stratification With Biomarker, run by Herlev Hospital at 1 site in Denmark.
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 1 inclusion and 1 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 9 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 1 site in Denmark. 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?
Yes. Results are posted in the registry (first posted 9 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
All Cause Mortality (time frame: 10 months after the inclusions period ends mortality data will be assessed). 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 NCT02643459, which also lists 4 linked publications.
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 9 Mar 2021.