title: Introduction of a prognostic biomarker to strengthen risk stratification of acutely admitted patients: rationale and design of the TRIAGE III cluster randomized interventional trial.
abstract: BACKGROUND
  Several biomarkers have shown to carry prognostic value beyond current triage algorithms and may aid in initial risk stratification of patients in the emergency department (ED). It has yet to be established if information provided by biomarkers can be used to prevent serious complications or deaths. Our aim is to determine whether measurement of the blood level of the biomarker soluble urokinase plasminogen activator receptor (suPAR) can enhance early risk stratification leading to reduced mortality, lower rate of complications, and improved patient flow in acutely admitted adult patients at the ED. The main hypothesis is that the availability of suPAR can reduce all-cause mortality, assessed at least 10 months after admission, by drawing attention towards patients with an unrecognized high risk, leading to improved diagnostics and treatment.
  
  
  METHODS
  The study is designed as a cross-over cluster randomized interventional trial. SuPAR is measured within 2 h after admission and immediately reported to the treating physicians in the ED. All ED physicians are educated in the prognostic capabilities of suPAR prior to the inclusion period. The inclusion period began January 11(th) 2016 and ends June 6(th) 2016. The study aims to include 10.000 patients in both the interventional and control arm. The results will be presented in 2017.
  
  
  CONCLUSIONS
  The present article aims to describe the design and rationale of the TRIAGE III study that will investigate whether the availability of prognostic information can improve outcome in acutely admitted patients. This might have an impact on health care organization and decision-making.
  
  
  BACKGROUND
  The trial is registered at clinicaltrials.gov (ID NCT02643459 , November 13, 2015) and at the Danish Data Protection agency (ID HGH-2015-042 I-Suite no. 04087).
authors: Department of Cardiology, Herlev Hospital, University of Copenhagen, Herlev Ringvej 75, 2730, Herlev, Denmark. andreas.hoejrup.sandoe.kristensen.01@regionh.dk.
authors: Andreas
authors: A
authors: Sandø
authors: Department of Cardiology, Herlev Hospital, University of Copenhagen, Herlev Ringvej 75, 2730, Herlev, Denmark.|Clinical Research Centre, Hvidovre Hospital, University of Copenhagen, Kettegård Alle 30, 2650, Hvidovre, Denmark.
authors: Martin
authors: M
authors: Schultz
authors: Clinical Research Centre, Hvidovre Hospital, University of Copenhagen, Kettegård Alle 30, 2650, Hvidovre, Denmark.
authors: Jesper
authors: J
authors: Eugen-Olsen
authors: Department of Anaesthesia, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark.
authors: Lars Simon
authors: LS
authors: Rasmussen
authors: Department of Cardiology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark.
authors: Lars
authors: L
authors: Køber
authors: Department of Cardiology, Herlev Hospital, University of Copenhagen, Herlev Ringvej 75, 2730, Herlev, Denmark.
authors: Erik
authors: E
authors: Kjøller
authors: Department of Emergency Medicine, Bispebjerg Hospital, University of Copenhagen, Bispebjerg Bakke 23, 2400, Copenhagen, Denmark.
authors: Birgitte Nybo
authors: BN
authors: Jensen
authors: Department of Emergency Medicine, Herlev Hospital, University of Copenhagen, Herlev Ringvej 75, 2730, Herlev, Denmark.
authors: Lisbet
authors: L
authors: Ravn
authors: Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, 1014, Copenhagen, Denmark.
authors: Theis
authors: T
authors: Lange
authors: Department of Cardiology, Herlev Hospital, University of Copenhagen, Herlev Ringvej 75, 2730, Herlev, Denmark.
authors: Kasper
authors: K
authors: Iversen
mesh_terms: D000208:Acute Disease / Q000401:mortality / Q000628:therapy*; D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000097:blood*; D003718:Denmark / Q000453:epidemiology; D004636:Emergency Service, Hospital; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies; D018570:Risk Assessment; D015996:Survival Rate / Q000639:trends; D014218:Triage / Q000458:organization & administration*
chemical_list: D015415:Biomarkers
keywords: Acute patients; Biomarkers; Emergency medicine; Risk stratification; SuPAR; Triage