The Safe Fast Track Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: D-dimer.
- Who it may be relevant to
- Registry conditions: Emergency Department, Non-specific Complaints. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Diagnostic test D-dimer
The investigators will measure a D-dimer test on participants and randomize on informing the physician on the value.
Primary outcome measures
- Length of stay [Time frame: From arrival to physician decision within 4 hours of arrival]
Secondary outcome measures (3)
- 7- and 30-day all-cause mortality from arrival [Time frame: From arrival until 30-days later]
- Hospital length of stay [Time frame: From arrival until final discharge within 1 month]
- Re-contacts to the emergency department within 30 days from arrival for any reason [Time frame: From arrival until 30-days later]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Denmark · 2 centers
- Esbjerg Hospital — Esbjerg
- Odense University Hospital — Odense
Identifiers
NCT: NCT06219486 · The SafeFT-study