Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06219486

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

Led by Odense University Hospital · Updated on 2025-04-09

1538

Participants Needed

2

Research Sites

4 weeks

Total Duration

On this page

Sponsors

O

Odense University Hospital

Lead Sponsor

S

Slagelse Sygehus

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of D-dimer testing in emergency departments to identify adult patients at very low risk of mortality. This study focuses on patients who arrive with non-specific complaints and aims to see if providing D-dimer test results to physicians can speed up the decision process for discharge. The trial is a randomized controlled study led by Odense University Hospital and addresses the challenge of increasing patient numbers in emergency settings. Participants will be randomly assigned to either usual care or care guided by D-dimer test results. The D-dimer test is performed on arrival, and in the intervention group, physicians are informed of the results to help guide treatment decisions. The study specifically targets patients who are stable, ambulatory, and have normal vital signs, with follow-up periods lasting up to 30 days. During the study, participants' length of stay from arrival to physician decision within 4 hours is measured as the primary outcome. Secondary outcomes include 7- and 30-day all-cause mortality, total hospital length of stay within one month, and any re-contacts to the emergency department within 30 days. Participants will undergo standard blood tests and vital sign assessments, and their progress will be monitored through hospital records and follow-up visits until discharge or 30 days after arrival.

CONDITIONS

Brief Title

The Safe Fast Track Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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)
Not Eligible

You will not qualify if you...

  • 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 that will be ordered on arrival regardless of this study
  • Previous participation in the study

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Up to 4 hours from arrival to physician decision

Participants receive usual care or care guided by D-dimer test results during their emergency department visit.

1 visit (in-person)

Follow-up

Duration - 30 days from arrival

Participants are monitored for outcomes including mortality, hospital length of stay, and emergency department re-contacts.

Follow-up contacts as needed within 30 days

Trial Site Locations

Total: 2 locations

1

Esbjerg Hospital

Esbjerg, Syd, Denmark, 6700

Actively Recruiting

2

Odense University Hospital

Odense, Syd, Denmark, 5000

Not Yet Recruiting

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Research Team

M

Mette Løkke, RN

M

Mikkel Brabrand, MD PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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