The Safe Fast Track Study

NCT06219486 | Recruiting

• 1 other identifier: The SafeFT-study
• Study Type: interventional
• Target: 1,538
• Locations: 1 country
• Sites: 2

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.

Conditions

Emergency Department; Non-specific Complaints

Keywords

D-dimer; Fast track; emergency

Outcome Measures

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)).

  From arrival to physician decision within 4 hours of arrival

Secondary Outcomes (3)

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

  From arrival until 30-days later

• Hospital length of stay

  From arrival until final discharge within 1 month

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

  From arrival until 30-days later

Study Arms (2)

Placebo

NO INTERVENTION

Usual care

Intervention

EXPERIMENTAL

Use of D-dimer to guide care of the patient

Diagnostic Test: D-dimer

Interventions

D-dimer DIAGNOSTIC_TEST

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead
• Slagelse Sygehus: collaborator
• Holbaek Sygehus: collaborator
• Esbjerg Hospital - University Hospital of Southern Denmark: collaborator

Study Sites (2)

Esbjerg Hospital

Esbjerg, Syd, 6700, Denmark

RECRUITING

Odense University Hospital

Odense, Syd, 5000, Denmark

NOT YET RECRUITING

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mette Løkke, RN

CONTACT

4551730068; mette.loekke@rsyd.dk

Mikkel Brabrand, MD PhD

CONTACT

4520577783; mikkel.brabrand@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2023
• First Posted: January 23, 2024
• Study Start: January 22, 2024
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)