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Clinical Trials/NCT06219486
NCT06219486
Recruiting
N/A

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

Odense University Hospital2 sites in 1 country1,538 target enrollmentJanuary 22, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Emergency Department
Sponsor
Odense University Hospital
Enrollment
1538
Locations
2
Primary Endpoint
Length of stay
Status
Recruiting
Last Updated
last year

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
January 22, 2024
End Date
August 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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)).

Secondary Outcomes

  • Hospital length of stay(From arrival until final discharge within 1 month)
  • Re-contacts to the emergency department within 30 days from arrival for any reason(From arrival until 30-days later)
  • 7- and 30-day all-cause mortality from arrival(From arrival until 30-days later)

Study Sites (2)

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