Medical Patients in the Emergency DepartmentNCT03108807
National Early Warning Score and D-dimer to Identify Medical Patients At Low Risk of 30-day Mortality
An observational study of Medical Patients in the Emergency Department, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medical Patients in the Emergency Department
- What is being tested?
- D-dimer test
- How many people
- 1,700 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Apr 2017to 19 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: An unselected group of consecutive patients in a Danish Emergency Department.
Who may be able to join
- Admission to the Emergency Department of Hospital of South West Jutland
- Requirement of any blood test
- Age 18 years
- Informed consent given
Who cannot join
- Age 18 years
- Informed consent not given
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- D-dimer test
- Keywords
- Emergency Department, Medical patients, D-dimer, National Early Warning Score, NEWS, 30-days mortality, Mortality
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-dimer testDiagnostic test
D-dimer test
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (2)
Hospital length of stay (LOS)
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
Measured: 30 days
Readmissions within 30 days
readmissions within 30 days after primary assessment will be determined for all patients using data extracted from the Danish National Patient Registry
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start24 Apr 2017
- Primary completion19 Aug 2017
- Study completion19 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Medical Patients in the 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Principal investigator, Mikkel Brabrand, Esbjerg Hospital - University Hospital of Southern Denmark
- Investigators
- Mikkel Brabrand, MD, PhD, Principal investigator, Esbjerg Hospital - University Hospital of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108807
- Sponsor's protocol ID
- S-20170005
- Status last verified
- Sep 2024
- First submitted
- 3 Apr 2017
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27053291Nickel 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.
PubMed 27339095Nickel 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.
PubMed 30981722
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03108807
- Acronym / sponsor ID
- S-20170005
- Keywords
- Emergency Department, Medical patients, D-dimer, National Early Warning Score, NEWS, 30-days mortality, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,700 participants (actual)
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern DenmarkUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 19 Aug 2017 (actual)
- Study completion
- 19 Aug 2017 (actual)
- First posted
- 11 Apr 2017 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- An unselected group of consecutive patients in a Danish Emergency Department.
Key inclusion criteria (4 listed)
- Admission to the Emergency Department of Hospital of South West Jutland
- Requirement of any blood test
- Age 18 years
- Informed consent given
Key exclusion criteria (2 listed)
- Age 18 years
- Informed consent not given
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-dimer testD-dimer test | Diagnostic test | – |
Primary outcome
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
2 secondary outcomes
Hospital length of stay (LOS)
Time frame: 30 days
Readmissions within 30 days
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 27053291Nickel 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.
- Background: PubMed 27339095Nickel 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.
- Derived from this study: PubMed 30981722Nickel 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mikkel Brabrand, MD, PhD principal investigator
Esbjerg Hospital - University Hospital of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medical Patients in the Emergency Department, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-days mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03108807, which also lists 3 linked publications.
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 19 Sep 2024.