The Safe Fast Track Study

Emergency Department Clinical Trial

— SafeFT  

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06219486
• Other study ID #: The SafeFT-study
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 22, 2024
• Est. completion date: August 1, 2024

Study information

• Verified date: January 2024
• Source: Odense University Hospital
• Contact: Mette Løkke, RN
• Phone: 4551730068
• Email: mette.loekke[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1538
• Est. completion date: August 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Emergency Department
• Non-specific Complaints

Intervention

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

Locations

Country	Name	City	State
Denmark	Esbjerg Hospital	Esbjerg	Syd
Denmark	Odense University Hospital	Odense	Syd

Sponsors (4)

Lead Sponsor	Collaborator
Odense University Hospital	Holbaek Sygehus, Hospital of South West Jutland, Slagelse Sygehus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7- and 30-day all-cause mortality from arrival	7- and 30-day all-cause mortality from arrival	From arrival until 30-days later
Secondary	Hospital length of stay	Hospital length of stay	From arrival until final discharge within 1 month
Secondary	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	From arrival until 30-days later