The Safe Fast Track Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOdense University Hospital
About this trial
Emergency departments (ED) internationally are treating an increasing number of patients.
Most require hospital services but some could be better cared for on alternative pathways.
D-dimer has some unique properties. It is non-specific and is elevated in many acute condi- tions; but conversely remains normal in the absence of significant disease. Previous studies have shown that having a normal D-dimer on arrival to the emergency department is associated with a very low risk of 30-day all-cause mortality.
The investigators propose a multicenter randomized controlled trial using D-dimer to identify patients at low risk and test if providing this information will change time to discharge disposition by the treating physician.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 or above
Able to provide oral and written informed consent in Danish
Blood tests ordered on arrival as part of standard of care
Ambulatory on arrival or walking to the ambulance (i.e., stable independent gait)
Disqualifiers
Unstable condition requiring immediate care in the resuscitation area
Triage level red (i.e., the most urgent patients)
Trauma (minor and major) patients
High likelihood of requiring a D-dimer analysis on clinical indications during the current hospital contact (e.g., suspected venous thromboembolic disease) that will be ordered on arrival regardless of this study
Trial design
Design model
Parallel
Treatments tested in this trial
D-dimer
Diagnostic testThe investigators will measure a D-dimer test on participants and randomize on informing the physician on the value.
Treatment groups
1,538 Participants
are divided into 2 treatment groupsGroup A: PlaceboNo intervention 0 interventions
Group B: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Length of stay
Length of initial emergency department stay (i.e., time from arrival to the emergency department to decision to discharge home or transfer to another department is made (as reported from the treating physician to the study nurse)).
Time frame
From arrival to physician decision within 4 hours of arrivalSecondary outcomes
1
7- and 30-day all-cause mortality from arrival
7- and 30-day all-cause mortality from arrival
Time frame
From arrival until 30-days later2
Hospital length of stay
Hospital length of stay
Time frame
From arrival until final discharge within 1 month3
Re-contacts to the emergency department within 30 days from arrival for any reason
Re-contacts to the emergency department within 30 days from arrival for any reason
Time frame
From arrival until 30-days laterSponsors and contacts
Click on the lead sponsor to view all of their trials.
Odense University Hospital
Lead sponsor
Slagelse Sygehus
Collaborator
Holbaek Sygehus
Collaborator
Esbjerg Hospital - University Hospital of Southern Denmark
Collaborator
Source ClinicalTrials.gov