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The Safe Fast Track Study

Use of D-dimers in the Emergency Department to Identify Adult Patients at Very Low Risk of Mortality for Fast-track Treatment - a Randomized Controlled Study

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06219486
Acronym
SafeFT
Enrollment
1538
Registered
2024-01-23
Start date
2024-01-22
Completion date
2025-08-01
Last updated
2025-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergency Department, Non-specific Complaints

Keywords

D-dimer, Fast track, emergency

Brief summary

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.

Interventions

DIAGNOSTIC_TESTD-dimer

The investigators will measure a D-dimer test on participants and randomize on informing the physician on the value.

Sponsors

Slagelse Sygehus
CollaboratorOTHER
Holbaek Sygehus
CollaboratorOTHER
Esbjerg Hospital - University Hospital of Southern Denmark
CollaboratorOTHER
Odense University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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) * Normal vital signs (i.e., National Early Warning Score < 3)

Exclusion criteria

* 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 * Previous participation in the study

Design outcomes

Primary

MeasureTime frameDescription
Length of stayFrom arrival to physician decision within 4 hours of arrivalLength 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)).

Secondary

MeasureTime frameDescription
7- and 30-day all-cause mortality from arrivalFrom arrival until 30-days later7- and 30-day all-cause mortality from arrival
Hospital length of stayFrom arrival until final discharge within 1 monthHospital length of stay
Re-contacts to the emergency department within 30 days from arrival for any reasonFrom arrival until 30-days laterRe-contacts to the emergency department within 30 days from arrival for any reason

Countries

Denmark

Contacts

Primary ContactMette Løkke, RN
mette.loekke@rsyd.dk4551730068
Backup ContactMikkel Brabrand, MD PhD
mikkel.brabrand@rsyd.dk4520577783

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026