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The Safe Fast Track Study (SafeFT)

O

Odense University Hospital

Status

Enrolling

Conditions

Non-specific Complaints
Emergency Department

Treatments

Diagnostic Test: D-dimer

Study type

Interventional

Funder types

Other

Identifiers

NCT06219486
The SafeFT-study

Details and patient eligibility

About

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.

Enrollment

1,538 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,538 participants in 2 patient groups

Placebo
No Intervention group
Description:
Usual care
Intervention
Experimental group
Description:
Use of D-dimer to guide care of the patient
Treatment:
Diagnostic Test: D-dimer

Trial documents
1

Trial contacts and locations

2

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Central trial contact

Mikkel Brabrand, MD PhD; Mette Løkke, RN

Data sourced from clinicaltrials.gov

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