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NCT Number: NCT06219486

The Safe Fast Track Study

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.

Recruiting

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Key information

Conditions

Emergency Department Disease Attributes Emergencies Non-specific Complaints Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Esbjerg Hospital, Esbjerg, Syd, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

D-dimer

Diagnostic Test

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

Primary outcomes

  1. Length of stay

    Time frame: From arrival to physician decision within 4 hours of arrival

    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)).

Secondary outcomes

  1. 7- and 30-day all-cause mortality from arrival

    Time frame: From arrival until 30-days later

    7- and 30-day all-cause mortality from arrival

  2. Hospital length of stay

    Time frame: From arrival until final discharge within 1 month

    Hospital length of stay

  3. Re-contacts to the emergency department within 30 days from arrival for any reason

    Time frame: From arrival until 30-days later

    Re-contacts to the emergency department within 30 days from arrival for any reason

Study contacts

Contact information is provided by the study sponsor or research team.

Mette Løkke, RN

CONTACT

[email protected]

4551730068

Mikkel Brabrand, MD PhD

CONTACT

[email protected]

4520577783

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Esbjerg Hospital - University Hospital of Southern Denmark
  • Holbaek Sygehus
  • Slagelse Sygehus

Registry information

Official study title

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

Acronym: SafeFT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 23, 2024
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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