Risk Stratification in Acute Care: The Meaning of suPAR Measurement in Triage (suPAR)

• ClinicalTrials.gov Identifier: NCT02643459
• Recruitment Status: Completed
• First Posted: December 31, 2015
• Results First Posted: March 9, 2021
• Last Update Posted: March 9, 2021
• Sponsor: Herlev Hospital
• Information provided by (Responsible Party): Martin Schultz, Herlev Hospital

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Conditions: Triage; Risk Stratification With Biomarker
• Intervention: Behavioral: suPAR measurement
• Enrollment: 20000

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Conventional	suPAR
Arm/Group Description	no suPAR measurement. Standard care.	suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR.
Period Title: Overall Study
Started	7901	8900
Completed	7901	8900
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Conventional	suPAR	Total
Arm/Group Description		no suPAR measurement. Standard care.	suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR.	Total of all reporting groups
Overall Number of Baseline Participants		7901	8900	16801
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	7901 participants	8900 participants	16801 participants
		60.9 (20.7)	60.4 (20.8)	60.6 (20.7)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	7901 participants	8900 participants	16801 participants
	Female	4175 52.8%	4689 52.7%	8864 52.8%
	Male	3726 47.2%	4211 47.3%	7937 47.2%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	7901 participants	8900 participants	16801 participants
	Hispanic or Latino	0 0.0%	0 0.0%	0 0.0%
	Not Hispanic or Latino	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	7901 100.0%	8900 100.0%	16801 100.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
Denmark	Number Analyzed	7901 participants	8900 participants	16801 participants
		7901	8900	16801

Outcome Measures

1. Primary Outcome

Title	All Cause Mortality
Description	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.
Time Frame	10 months after the inclusions period ends mortality data will be assessed

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional	suPAR
Arm/Group Description:	no suPAR measurement. Standard care.	suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR.
Overall Number of Participants Analyzed	7901	8900
Measure Type: Count of Participants; Unit of Measure: Participants
	1126 14.3%	1241 13.9%

2. Secondary Outcome

Title	All Cause Mortality
Description	Mortality within 30 days
Time Frame	1 months after index admission mortality data will assessed

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional	suPAR
Arm/Group Description:	no suPAR measurement. Standard care.	suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR.
Overall Number of Participants Analyzed	7901	8900
Measure Type: Count of Participants; Unit of Measure: Participants
	319 4.0%	359 4.0%

3. Secondary Outcome

Title	Number of Discharges From the Emergency Room Within 24 Hours
Description	How many patients are discharged directly from the ED
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional	suPAR
Arm/Group Description:	no suPAR measurement. Standard care.	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. suPAR measurement: 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.
Overall Number of Participants Analyzed	7901	8900
Measure Type: Count of Participants; Unit of Measure: Participants
	3934 49.8%	4352 48.9%

4. Secondary Outcome

Title	Number of Admissions to the Medical Ward
Description	Number of Participants with Admissions to the Medical War
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional	suPAR
Arm/Group Description:	no suPAR measurement. Standard care.	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. suPAR measurement: 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.
Overall Number of Participants Analyzed	7901	8900
Measure Type: Count of Participants; Unit of Measure: Participants
	3500 44.3%	3738 42.0%

5. Secondary Outcome

Title	Number of Patients With an Admission to the Intensive Care Unit
Description	Number of Participants with transfer to the ICU
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional	suPAR
Arm/Group Description:	no suPAR measurement. Standard care.	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. suPAR measurement: 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.
Overall Number of Participants Analyzed	7901	8900
Measure Type: Count of Participants; Unit of Measure: Participants
	1027 13.0%	1157 13.0%

6. Secondary Outcome

Title	Number of Patients With New Cancer Diagnosis in Control vs Intervention Groups
Description	[Not Specified]
Time Frame	10 months after inclusion period ends

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional	suPAR
Arm/Group Description:	no suPAR measurement. Standard care.	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. suPAR measurement: 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.
Overall Number of Participants Analyzed	7901	8900
Measure Type: Count of Participants; Unit of Measure: Participants
	687 8.7%	917 10.3%

7. Secondary Outcome

Title	Length of Stay During Admission.
Description	Length of stay in days during the admission
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional	suPAR
Arm/Group Description:	no suPAR measurement. Standard care.	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. suPAR measurement: 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.
Overall Number of Participants Analyzed	7901	8900
Mean (Standard Error); Unit of Measure: Days
	4.53 (8.7)	4.39 (8.27)

8. Secondary Outcome

Title	Number of Readmissions
Description	Patients will be followed using central registers. All new admissions within 90 days of the same patient is defined as readmissions.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional	suPAR
Arm/Group Description:	no suPAR measurement. Standard care.	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. suPAR measurement: 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.
Overall Number of Participants Analyzed	7901	8900
Measure Type: Count of Participants; Unit of Measure: Participants
	687 8.7%	917 10.3%

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	Data on all outcomes were collected from national registries.
Arm/Group Title	Conventional		suPAR
Arm/Group Description	no suPAR measurement. Standard care.		suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR.
All-Cause Mortality
	Conventional		suPAR
	Affected / at Risk (%)		Affected / at Risk (%)
Total	1126/7901 (14.25%)		1241/8900 (13.94%)
Serious Adverse Events
	Conventional		suPAR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7901 (0.00%)		0/8900 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Conventional		suPAR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	700/7901 (8.86%)		777/8900 (8.73%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
New cancer diagnosis †	700/7901 (8.86%)	700	777/8900 (8.73%)	777
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. Martin Schultz
• Organization: Herlev Hospital, Department of Cardiology
• Phone: 004538683868
• EMail: martin.schultz@regionh.dk

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Schultz 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.

Schultz 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.

Sando 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.

• Responsible Party: Martin Schultz, Herlev Hospital
• ClinicalTrials.gov Identifier: NCT02643459
• Other Study ID Numbers: HerlevH01
• First Submitted: November 13, 2015
• First Posted: December 31, 2015
• Results First Submitted: February 25, 2019
• Results First Posted: March 9, 2021
• Last Update Posted: March 9, 2021