The Management of Transient Loss of Consciousness and Suspected Syncope in European Emergency Departments (SEED)

March 22, 2023 updated by: NHS Lothian

The Management of Transient Loss of Consciousness (TLOC) and Suspected Syncope in European Emergency Departments: a Prospective Cohort Study

Prospective multi centre cohort study examining the clinical presentation, diagnostic tests, and management of adult Emergency Department (ED) patients presenting with Transient Loss of Consciousness (TLOC) either undifferentiated or thought to be of syncopal origin.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Syncope is a common ED problem. The three underlying causes are reflex (simple faint), orthostatic hypotension (blood pressure fall on standing) and cardiac disease (structural heart disease or cardiac dysrhythmia). Diagnosis is difficult and is not apparent in ~50% of patients after assessment. For the first time, European Society of Cardiology (ESC) guidelines incorporating ED management of patients presenting with TLOC, either undifferentiated or thought to be of syncopal origin, have been produced.

However, very little is currently known about the use of diagnostic algorithms and management of this patient group in EDs across Europe. As a result, the application of guidelines and the management of TLOC by European Society of Emergency Medicine (EUSEM) members in different countries and hospitals, cannot yet be recommended for use in settings other than those where they have been successfully validated.

This study aims to describe the prevalence, clinical presentation, current assessment, management strategies and ESC risk categories of patients presenting with TLOC (undifferentiated or thought to be of syncopal origin) to the ED, and will provide data to help identify the gaps in our knowledge and practice, and areas where further research and development work is required to fully implement European Society of Cardiology (ESC) guidelines within European EDs.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
952

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Albania
      • Durres, Albania
        • Regional Hospital Durres
      • Elbasan, Albania
        • Regional Hospital Centre "Xh. Kongoli" Elbasan
      • Sarande, Albania
        • Spitali "Petro Nako" Sarandra
      • Shkodra, Albania
        • Regional Hospital Shkoder
      • Tirana, Albania
        • University Hospital Centre "Mother Theresa" Tirana
  • Austria
      • Vienna, Austria
        • Allgemeines Krankenhaus der Stadt Wien/ Universitätskliniken
      • Vienna, Austria
        • Klinik Donaustadt
  • Belgium
      • Brugge, Belgium
        • AZ Sint Jan Brugge
      • Eeklo, Belgium
        • AZ Alma Eeklo
      • Ghent, Belgium
        • Ghent University Hospital
      • Lier, Belgium
        • Heilig Hartziekenhuis Lier
  • Czechia
      • Králová, Czechia
        • University Hospital Hradec Kralove
      • Praha, Czechia
        • University Hospital Kralovske Vinohrady
  • Denmark
      • Herning, Denmark
        • Regionshospitalet Gødstrup
      • Hillerød, Denmark
        • Nordsjællands Hospital
      • Randers, Denmark
        • Regionshospitalet Randers
      • Roskilde, Denmark
        • Sjællands Universitetshospital
      • Vildbjerg, Denmark
        • Regionshospitalet Midt
  • Finland
      • Helsinki, Finland
        • Kanta-Häme Central Hospital
  • France
      • Besançon, France
        • CHU Besançon
      • Caen, France
        • CHU Caen
      • Clermont-Ferrand, France
        • CHU Clermond-Ferrand
      • Lyon, France
        • Medipole
      • Tours, France
        • CHU Tours
  • Greece
      • Athens, Greece
        • University General Hospital Attikon
      • Heraklion, Greece
        • General Hospital Venizeleio
      • Thessaloníki, Greece
        • AHEPA Univesrity General Hospital of Thessaloniki
  • Hungary
      • Budapest, Hungary
        • Semmelweis University Department of Emergency Medicine
  • Italy
      • Bologna, Italy
        • ED Azienda Ospedaliera Universitaria di Bologna (Sant'Orsola Hospital)
      • Catania, Italy
        • ED Azienda Ospedaliera-universitaria di Catania (San Marco Hospital)
      • Firenze, Italy
        • ED Azienda USL Toscana Centro, Firenze (San Giovanni di Dio Hospital)
      • Perugia, Italy
        • Azienda Ospedaliera di Perugia (Santa Maria Della Misericordia Hospital)
      • Verona, Italy
        • ED Azienda Ospedaliera-Universitaria integrata (Borgo Trento Hospital)
  • Malta
      • Birkirkara, Malta
        • Mater dei hospital
      • Victoria, Malta
        • Gozo General Hospital
  • Norway
      • Trondheim, Norway
        • St. Olav's University Hospital
  • Poland
      • Wrocław, Poland
        • Wroclaw University Hospital
  • Romania
      • Cluj-Napoca, Romania
        • Cluj Napoca County Emergency Clinical Hospital
      • Iaşi, Romania
        • Saint Spiridon County Hospital
  • Serbia
      • Belgrad, Serbia
        • Emergency Center Belgrade, Clinical Centre Belgade
      • Niš, Serbia
        • Clinical Centre of Nis
      • Zaječar, Serbia
        • Emergency Department Zaječar, Health Center Zaječar
  • Spain
      • Alicante, Spain
        • Hospital Dr. Balmis
      • Barcelona, Spain
        • Hospital Universitari de Bellvitge
      • Barcelona, Spain
        • Hospital Clinic Barcelona
      • Barcelona, Spain
        • Hospital de Terrassa
      • Barcelona, Spain
        • Hospital Universitari de Vic
  • Turkey
      • Ankara, Turkey
        • Gazi University Medical Faculty Department of Emergency Medicine
      • Ankara, Turkey
        • Medical Science University Ankara Education and Research Hospital Department of Emergency Medicine
      • Karaman, Turkey
        • Karamanoglu Mehmetbey University Karaman Education and Research Hospital Department of Emergency Medicine
      • Konya, Turkey
        • Necmettin Erbakan University Medical Faculty Department of Emergency Medicine
      • Şanlıurfa, Turkey
        • Medical Science University Sanliurfa Mehmet Akif Inan Education and Research Hospital Department of Emergency Medicine
  • United Kingdom
      • Coventry, United Kingdom
        • University Hospital Coventry & Warwickshire
      • Kirkcaldy, United Kingdom
        • Victoria Hospital
      • Livingston, United Kingdom
        • St Johns Hospital, Livingston
      • Preston, United Kingdom
        • Royal Preston Hospital
    • Midlothian
      • Edinburgh, Midlothian, United Kingdom, EH16 4SA
        • Royal Infirmary of Edinburgh

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults 18 years of age and older presenting to the ED over a two-week period with TLOC, either undifferentiated or thought to be of syncopal origin.

Description

Inclusion Criteria:

  • Adult patients (≥18 years old) assessed in the ED with TLOC thought to be of syncopal origin.

Exclusion Criteria:

  • Inability to consent
  • Patient in custody or prison
  • Aged <18 years
  • TLOC thought to be due to neurological seizure (e.g., epilepsy/alcohol or drug withdrawal) or trauma

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Participant age
Time Frame: Admission
Participant age
Admission
Participant gender
Time Frame: Admission
Participant gender
Admission
Mode of arrival
Time Frame: Admission
Mode of arrival
Admission
Referral source
Time Frame: Admission
Referral source
Admission
Presence of any European Society of Cardiology (ESC) syncope high-risk history features
Time Frame: Admission
Which European Society of Cardiology syncope high-risk history features are present
Admission
ESC high-risk 'past medical history' features
Time Frame: Admission
Which European Society of Cardiology syncope high-risk 'past medical history' features are present
Admission
Other medical comorbidities
Time Frame: Admission
Other medical comorbidities
Admission
Rockwood Clinical Frailty Scale score
Time Frame: Admission
Rockwood Clinical Frailty Scale is a well validated score ranging from 1 (Very Fit) to 9 (Terminally Ill) with defined descriptions for each category.
Admission
ESC high risk 'physical examination' factors
Time Frame: Admission
ESC high risk 'physical examination' factors
Admission
Blood pressure (BP) on admission
Time Frame: Admission
First Blood pressure (BP) measure in the Emergency Department in mmHg
Admission
Pulse rate on admission
Time Frame: Admission
First pulse rate measured in the Emergency Department in beats per minute
Admission
Lying/standing systolic BP difference on admission
Time Frame: Admission
First lying/standing systolic BP difference measured in the Emergency Department in mmHg
Admission
Number of participants with abnormal Electrocardiogram (ECG) readings
Time Frame: Admission
Number of participants with abnormal ECG readings
Admission
Troponin levels
Time Frame: Admission
Troponin levels
Admission
D-dimer levels
Time Frame: Admission
D-dimer levels
Admission
Copeptin levels
Time Frame: Admission
Copeptin levels
Admission
Natriuretic peptides levels
Time Frame: Admission
Natriuretic peptides levels
Admission
ED clinician diagnosis
Time Frame: Admission
ED clinician diagnosis - descriptive
Admission
Patient destination
Time Frame: Admission
Descriptive options: Admitted to Observation/Clinical Decision Unit/Same Day Emergency Care unit/hospital floor with telemetry monitoring/hospital floor with no telemetry monitoring. Discharged to outpatient follow up/family doctor/General Practitioner care/home with no follow up
Admission
Reason(s) for admission
Time Frame: Admission
Reason(s) for admission
Admission
Whether driving and occupation advice given
Time Frame: Admission
Whether driving and occupation advice given
Admission
Status at discharge from hospital
Time Frame: 30 days
Status at discharge from hospital
30 days
Length of hospital stay in days
Time Frame: 30 days
Length of hospital stay in days
30 days
Hospital discharge diagnosis
Time Frame: 30 days
Hospital discharge diagnosis
30 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NHS Lothian

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Matt Reed, University of Edinburgh

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 12, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 2, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 2, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 7, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AC22033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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