National Early Warning Score and D-dimer to Identify Medical Patients at Low Risk of 30-day Mortality

September 11, 2017 updated by: Mikkel Brabrand, Hospital of South West Jutland

Combined Use of the National Early Warning Score and D-dimer to Identify Medical Patients at Low Risk of 30-day Mortality in a Danish Emergency Department

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Large increases in emergency admissions are raising concerns about whether all admissions are necessary. If there was a fast and reliable system that could be used to determine the risk of all medical patients, many low-risk patients could be safely returned to primary care or outpatient follow-up clinics.

The investigators wish to determine, if the combination of the National Early Warning Score and plasma D-dimer levels can be used to identify patients at low risk of mortality within 30 days in an unselected group of medical patients presenting to a Danish Emergency Department.

This is a prospective observational study that will be performed on adult medical patients referred to the Emergency Department of a Danish hospital to be assessed for possible admission. The study will be performed in the Emergency Department of Hospital of South West Jutland in the region of Southern Denmark.

Study Type

Observational

Enrollment (Actual)

1700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Esbjerg, Denmark, 6700
        • Hospital of South West Jutland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Age 18 years
  • Informed consent not given

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-days mortality
Time Frame: 30 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital length of stay (LOS)
Time Frame: 30 days
length of stay will be calculated from the time of the patients' arrival at the hospital to the moment of the discharge for all patients using data extracted from the Danish National Patient Registry
30 days
Readmissions within 30 days
Time Frame: 30 days
readmissions within 30 days after primary assessment will be determined for all patients using data extracted from the Danish National Patient Registry
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital of South West Jutland

Collaborators

University of Southern Denmark

Investigators

  • Principal Investigator: Mikkel Brabrand, MD, PhD, Hospital of South West Jutland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2017

Primary Completion (Actual)

August 19, 2017

Study Completion (Actual)

August 19, 2017

Study Registration Dates

First Submitted

April 3, 2017

First Submitted That Met QC Criteria

April 6, 2017

First Posted (Actual)

April 11, 2017

Study Record Updates

Last Update Posted (Actual)

September 12, 2017

Last Update Submitted That Met QC Criteria

September 11, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-20170005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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