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

Tracking Information

• First Submitted Date: November 13, 2015
• First Posted Date: December 31, 2015
• Results First Submitted Date: February 25, 2019
• Results First Posted Date: March 9, 2021
• Last Update Posted Date: March 9, 2021
• Study Start Date: January 2016
• Actual Primary Completion Date: April 6, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 16, 2021)

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.

Original Primary Outcome Measures (submitted: December 29, 2015)

All cause mortality [ Time Frame: 1 year after index admission 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.

Current Secondary Outcome Measures (submitted: February 16, 2021)

• All Cause Mortality [ Time Frame: 1 months after index admission mortality data will assessed ]
  Mortality within 30 days
• Number of Discharges From the Emergency Room Within 24 Hours [ Time Frame: 24 hours ]
  How many patients are discharged directly from the ED
• Number of Admissions to the Medical Ward [ Time Frame: 30 days ]
  Number of Participants with Admissions to the Medical War
• Number of Patients With an Admission to the Intensive Care Unit [ Time Frame: 30 days ]
  Number of Participants with transfer to the ICU
• 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 ]
  Length of stay in days during the admission
• Number of Readmissions [ Time Frame: 90 days ]
  Patients will be followed using central registers. All new admissions within 90 days of the same patient is defined as readmissions.

Original Secondary Outcome Measures (submitted: December 29, 2015)

• All cause mortality [ Time Frame: 1 , 3 and 24 months after index admission mortality data will assessed ]
• Number of discharges from the emergency room within 24 hours [ Time Frame: 30 days ]
• 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: 3, 6, 12 and 24 months. ]
• Length of stay during admission. [ Time Frame: 30 days ]
• Number of readmissions [ Time Frame: 30 and 90 days ]
  Patients will be followed using central registers. All new admissions within 91 days of the same patient is defined as readmissions.
• All cause mortality and secondary outcomes in age specific groups aged 65 or older [ Time Frame: up to 12 months ]
  with regard to number of readmissions at 30 and 90 days, Length of stay during admission at 30 days, number of patients with an admission to the intensive care unit at 30 days, number of admissions to the medical ward at 30 days, number of discharges within 24 hours from the emergency department at 30 days and all cause mortality at 30-, 90- and 365 days.
• All cause mortality - Subgroup analysis of patients diagnosed with cardiovascular disease [ Time Frame: 12 months ]
• All cause mortality - Subgroup analysis of patients diagnosed with cancer [ Time Frame: 12 months ]
• All cause mortality - Subgroup analysis of patients diagnosed with infections [ Time Frame: 12 months ]
• All cause mortality - Subgroup analysis of patients diagnosed with Neurological disease [ Time Frame: 12 months ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Risk Stratification in Acute Care: The Meaning of suPAR Measurement in Triage
• Official Title: Introduction of Soluble Urokinase Plasminogen Activating Receptor in Acute Care as a Prognostic Biomarker to Strengthen Risk Stratification of Acutely Admitted Patients
• Brief Summary: 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Triage
• Risk Stratification With Biomarker

Intervention

Behavioral: 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.

Study Arms

• No Intervention: Conventional
  no suPAR measurement. Standard care.
• Experimental: suPAR
  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.
  Intervention: Behavioral: suPAR measurement

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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 30, 2016): 20000
• Original Estimated Enrollment (submitted: December 29, 2015): 38000
• Actual Study Completion Date: April 6, 2017
• Actual Primary Completion Date: April 6, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients presenting in Pediatric, Gynecological or Obstetric units. Patients not being examined with blood samples.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT02643459
• Other Study ID Numbers: HerlevH01
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Martin Schultz, Herlev Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Herlev Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Kasper K Iversen, MD, DMSci; Department of Cardiology, Herlev Hospital

• PRS Account: Herlev Hospital
• Verification Date: February 2021