NCT03108807

Brief Summary

The aim is to determine if the National Early Warning Score combined with plasma D-dimer levels can be used in risk stratification of acutely ill medical patients presenting to a Danish Emergency Department. The investigators wish to identify patients at low risk of mortality within 30 days.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

April 24, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2017

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

4 months

First QC Date

April 3, 2017

Last Update Submit

September 10, 2024

Conditions

Keywords

Emergency DepartmentMedical patientsD-dimerNational Early Warning ScoreNEWS30-days mortalityMortality

Outcome Measures

Primary Outcomes (1)

  • 30-days mortality

    mortality within 30 days after assessment will be determined for all patients using data extracted from the Danish Civil Registration System patients using data extracted from the Danish Civil Registration System

    30 days

Secondary Outcomes (2)

  • Hospital length of stay (LOS)

    30 days

  • Readmissions within 30 days

    30 days

Interventions

D-dimer testDIAGNOSTIC_TEST

D-dimer test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

An unselected group of consecutive patients in a Danish Emergency Department.

You may qualify if:

  • Admission to the Emergency Department of Hospital of South West Jutland
  • Requirement of any blood test
  • Age 18 years
  • Informed consent given

You may not qualify if:

  • Age 18 years
  • Informed consent not given

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of South West Jutland

Esbjerg, 6700, Denmark

Location

Related Publications (3)

  • Nickel CH, Kuster T, Keil C, Messmer AS, Geigy N, Bingisser R. Risk stratification using D-dimers in patients presenting to the emergency department with nonspecific complaints. Eur J Intern Med. 2016 Jun;31:20-4. doi: 10.1016/j.ejim.2016.03.006. Epub 2016 Apr 1.

    PMID: 27053291BACKGROUND
  • Nickel CH, Kellett J, Cooksley T, Bingisser R, Henriksen DP, Brabrand M. Combined use of the National Early Warning Score and D-dimer levels to predict 30-day and 365-day mortality in medical patients. Resuscitation. 2016 Sep;106:49-52. doi: 10.1016/j.resuscitation.2016.06.012. Epub 2016 Jun 20.

    PMID: 27339095BACKGROUND
  • Nickel CH, Kellett J, Nieves Ortega R, Lyngholm L, Wasingya-Kasereka L, Brabrand M. Mobility Identifies Acutely Ill Patients at Low Risk of In-Hospital Mortality: A Prospective Multicenter Study. Chest. 2019 Aug;156(2):316-322. doi: 10.1016/j.chest.2019.04.001. Epub 2019 Apr 11.

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mikkel Brabrand, MD, PhD

    Esbjerg Hospital - University Hospital of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, clinical associate professor

Study Record Dates

First Submitted

April 3, 2017

First Posted

April 11, 2017

Study Start

April 24, 2017

Primary Completion

August 19, 2017

Study Completion

August 19, 2017

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations