The Safe Fast Track Study

Not Applicable

Not yet recruiting

• Conditions: Emergency Department; Non-specific Complaints
• Interventions: Diagnostic Test: D-dimer

• Registration Number: NCT06219486
• Lead Sponsor: Odense University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-10
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-12
• Last Update Submitted: 2024-01-12
• Study Start: 2024-01-22
• Study First Posted: 2024-01-23
• Last Update Posted: 2024-01-23
• Primary Completion: 2024-07-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1538

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)

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	D-dimer	Use of D-dimer to guide care of the patient

Primary Outcome Measures

Name	Time	Method
Length of stay	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 Outcome Measures

Name	Time	Method
Hospital length of stay	From arrival until final discharge within 1 month	Hospital length of stay
Re-contacts to the emergency department within 30 days from arrival for any reason	From arrival until 30-days later	Re-contacts to the emergency department within 30 days from arrival for any reason
7- and 30-day all-cause mortality from arrival	From arrival until 30-days later	7- and 30-day all-cause mortality from arrival

Trial Locations

Locations (2)

Odense University Hospital; 🇩🇰 Odense, Syd, Denmark

Esbjerg Hospital; 🇩🇰 Esbjerg, Syd, Denmark