The Safe Fast Track Study (SafeFT)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Emergency Department; Non-specific Complaints
• Intervention / Treatment: Diagnostic test: D-dimer

• Study Type: Interventional
• Enrollment (Estimated): 1538
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mette Løkke, RN; Phone Number: 4551730068; Email: mette.loekke@rsyd.dk
• Study Contact Backup: Name: Mikkel Brabrand, MD PhD; Phone Number: 4520577783; Email: mikkel.brabrand@rsyd.dk

Study Locations

• Denmark
  • Syd
    • Esbjerg, Syd, Denmark, 6700
      • Esbjerg Hospital
      • Contact: Mette Rahbek, RN; Phone Number: 4579182000; Email: mette.rahbek.kristensen@rsyd.dk
    • Odense, Syd, Denmark, 5000
      • Odense University Hospital
      • Contact: Mette Løkke, RN; Phone Number: 4551730068; Email: mette.loekke@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Placebo; Usual care
Experimental: Intervention; Use of D-dimer to guide care of the patient	Diagnostic test: D-dimer; The investigators will measure a D-dimer test on participants and randomize on informing the physician on the value.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
7- and 30-day all-cause mortality from arrival	7- and 30-day all-cause mortality from arrival	From arrival until 30-days later
Hospital length of stay	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	Re-contacts to the emergency department within 30 days from arrival for any reason	From arrival until 30-days later

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: Holbaek Sygehus; Hospital of South West Jutland; Slagelse Sygehus

Study record dates

Study Major Dates

• Study Start (Estimated): January 22, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: December 10, 2023
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Estimated): January 23, 2024

Study Record Updates

• Last Update Posted (Estimated): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: emergency; D-dimer; Fast track
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Fibrin fragment D
• Other Study ID Numbers: The SafeFT-study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not allowed due to Danish law

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No