The Safe Fast Track Study

NCT ID: NCT06219486

Last Updated: 2025-04-09

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1538 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-22

Study Completion Date

2025-08-01

Brief Summary

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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

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Conditions

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Emergency Department Non-specific Complaints

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Placebo

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Use of D-dimer to guide care of the patient

Group Type EXPERIMENTAL

D-dimer

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Slagelse Sygehus

OTHER

Sponsor Role collaborator

Holbaek Sygehus

OTHER

Sponsor Role collaborator

Esbjerg Hospital - University Hospital of Southern Denmark

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Esbjerg Hospital

Esbjerg, Syd, Denmark

Site Status RECRUITING

Odense University Hospital

Odense, Syd, Denmark

Site Status NOT_YET_RECRUITING

Countries

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Denmark

Central Contacts

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Mette Løkke, RN

Role: CONTACT

4551730068

Mikkel Brabrand, MD PhD

Role: CONTACT

4520577783

Facility Contacts

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Mette Rahbek, RN

Role: primary

4579182000

Mette Løkke, RN

Role: primary

4551730068

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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The SafeFT-study

Identifier Type: -

Identifier Source: org_study_id

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