Emergency DepartmentSafeFTNCT06219486
The Safe Fast Track Study
A study testing D-dimer in people with Emergency Department and Non-specific Complaints, run by Odense University Hospital at 2 sites in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Department, Non-specific Complaints
- What is being tested?
- D-dimer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,538 participants
- Where
- 2 sitesDenmark
- Study dates
- 22 Jan 2024to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Esbjerg Hospital
Esbjerg, Syd, 6700
Mette Rahbek, RN, 4579182000, mette.rahbek.kristensen@rsyd.dk
- Not yet recruiting
Odense University Hospital
Odense, Syd, 5000
Mette Løkke, RN, 4551730068, mette.loekke@rsyd.dk
About this study
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
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.
Read more
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.
- Conditions
- Emergency Department, Non-specific Complaints
- Being tested
- D-dimer
- Keywords
- D-dimer, Fast track, emergency
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-dimerDiagnostic test
The investigators will measure a D-dimer test on participants and randomize on informing the physician on the value.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | No intervention | Usual care |
| Intervention | Experimental | Use of D-dimer to guide care of the patient Receives: Diagnostic Test: D-dimer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)).
Measured: From arrival to physician decision within 4 hours of arrival
Secondary outcomes (3)
7- and 30-day all-cause mortality from arrival
7- and 30-day all-cause mortality from arrival
Measured: From arrival until 30-days later
Hospital length of stay
Hospital length of stay
Measured: 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
Measured: From arrival until 30-days later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start22 Jan 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency DepartmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,538 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Slagelse Sygehus, Holbaek Sygehus, Esbjerg Hospital - University Hospital of Southern Denmark
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219486
- Sponsor's protocol ID
- The SafeFT-study
- Acronym
- SafeFT
- Status last verified
- Apr 2025
- First submitted
- 10 Dec 2023
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not allowed due to Danish law
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06219486
- Acronym / sponsor ID
- SafeFT / The SafeFT-study
- Conditions
- Emergency Department, Non-specific Complaints
- Keywords
- D-dimer, Fast track, emergency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,538 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Slagelse Sygehus, Holbaek Sygehus, Esbjerg Hospital - University Hospital of Southern Denmark
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | No intervention | –Usual care |
| Intervention | Experimental | Diagnostic Test: D-dimerUse of D-dimer to guide care of the patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-dimerThe investigators will measure a D-dimer test on participants and randomize on informing the physician on the value. | Diagnostic test | Intervention |
Primary outcome
Length of stay
Time frame: From arrival to physician decision within 4 hours of arrival
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)).
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: No. Not allowed due to Danish law
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D-dimer in people with Emergency Department and Non-specific Complaints, run by Odense University Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mette Løkke, RN (4551730068, mette.loekke@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay (time frame: From arrival to physician decision within 4 hours of arrival). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.