Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1538 participants
INTERVENTIONAL
2024-01-22
2025-08-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Placebo
Usual care
No interventions assigned to this group
Intervention
Use of D-dimer to guide care of the patient
D-dimer
The investigators will measure a D-dimer test on participants and randomize on informing the physician on the value.
Interventions
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D-dimer
The investigators will measure a D-dimer test on participants and randomize on informing the physician on the value.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Slagelse Sygehus
OTHER
Holbaek Sygehus
OTHER
Esbjerg Hospital - University Hospital of Southern Denmark
OTHER
Odense University Hospital
OTHER
Responsible Party
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Locations
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Esbjerg Hospital
Esbjerg, Syd, Denmark
Odense University Hospital
Odense, Syd, Denmark
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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The SafeFT-study
Identifier Type: -
Identifier Source: org_study_id
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