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

NCT ID: NCT05571254

Last Updated: 2023-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

952 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-12

Study Completion Date

2022-12-02

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Syncope

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Data collection

All patients will have a focussed Case Report Form completed collecting routine data describing the prevalence, clinical presentation, assessment, management and ESC risk category of patients, at the time or shortly after the patients ED attendance.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NHS Lothian

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matt Reed

Role: STUDY_CHAIR

University of Edinburgh

Locations

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Regional Hospital Durres

Durrës, , Albania

Site Status

Regional Hospital Centre "Xh. Kongoli" Elbasan

Elbasan, , Albania

Site Status

Spitali "Petro Nako" Sarandra

Sarandë, , Albania

Site Status

Regional Hospital Shkoder

Shkodër, , Albania

Site Status

University Hospital Centre "Mother Theresa" Tirana

Tirana, , Albania

Site Status

Allgemeines Krankenhaus der Stadt Wien/ Universitätskliniken

Vienna, , Austria

Site Status

Klinik Donaustadt

Vienna, , Austria

Site Status

AZ Sint Jan Brugge

Bruges, , Belgium

Site Status

AZ Alma Eeklo

Eeklo, , Belgium

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Ghent University Hospital

Ghent, , Belgium

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Heilig Hartziekenhuis Lier

Lier, , Belgium

Site Status

University Hospital Hradec Králové

Králová, , Czechia

Site Status

University Hospital Královské Vinohrady

Prague, , Czechia

Site Status

Regionshospitalet Gødstrup

Herning, , Denmark

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Nordsjællands Hospital

Hillerød, , Denmark

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Regionshospitalet Randers

Randers, , Denmark

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Sjællands Universitetshospital

Roskilde, , Denmark

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Regionshospitalet Midt

Vildbjerg, , Denmark

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Kanta-Häme Central Hospital

Helsinki, , Finland

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CHU Besançon

Besançon, , France

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CHU Caen

Caen, , France

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CHU Clermond-Ferrand

Clermont-Ferrand, , France

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Medipole

Lyon, , France

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CHU Tours

Tours, , France

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University General Hospital ATTIKON

Athens, , Greece

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General Hospital Venizeleio

Heraklion, , Greece

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AHEPA Univesrity General Hospital of Thessaloniki

Thessaloniki, , Greece

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Semmelweis University Department of Emergency Medicine

Budapest, , Hungary

Site Status

ED Azienda Ospedaliera Universitaria di Bologna (Sant'Orsola Hospital)

Bologna, , Italy

Site Status

ED Azienda Ospedaliera-universitaria di Catania (San Marco Hospital)

Catania, , Italy

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ED Azienda USL Toscana Centro, Firenze (San Giovanni di Dio Hospital)

Florence, , Italy

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Azienda Ospedaliera di Perugia (Santa Maria Della Misericordia Hospital)

Perugia, , Italy

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ED Azienda Ospedaliera-Universitaria integrata (Borgo Trento Hospital)

Verona, , Italy

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Mater Dei Hospital

Birkirkara, , Malta

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Gozo General Hospital

Victoria, , Malta

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St. Olav's University Hospital

Trondheim, , Norway

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Wroclaw University Hospital

Wroclaw, , Poland

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Cluj Napoca County Emergency Clinical Hospital

Cluj-Napoca, , Romania

Site Status

Saint Spiridon County Hospital

Iași, , Romania

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Emergency Center Belgrade, Clinical Centre Belgade

Belgrade, , Serbia

Site Status

Clinical Centre of Niš

Niš, , Serbia

Site Status

Emergency Department Zaječar, Health Center Zaječar

Zaječar, , Serbia

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Hospital Dr. Balmis

Alicante, , Spain

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Hospital clinic Barcelona

Barcelona, , Spain

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Hospital de Terrassa

Barcelona, , Spain

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Hospital Universitari de Bellvitge

Barcelona, , Spain

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Hospital Universitari de Vic

Barcelona, , Spain

Site Status

Gazi University Medical Faculty Department of Emergency Medicine

Ankara, , Turkey (Türkiye)

Site Status

Medical Science University Ankara Education and Research Hospital Department of Emergency Medicine

Ankara, , Turkey (Türkiye)

Site Status

Karamanoglu Mehmetbey University Karaman Education and Research Hospital Department of Emergency Medicine

Karaman, , Turkey (Türkiye)

Site Status

Necmettin Erbakan University Medical Faculty Department of Emergency Medicine

Konya, , Turkey (Türkiye)

Site Status

Medical Science University Sanliurfa Mehmet Akif Inan Education and Research Hospital Department of Emergency Medicine

Sanliurfa, , Turkey (Türkiye)

Site Status

Royal Infirmary of Edinburgh

Edinburgh, Midlothian, United Kingdom

Site Status

University Hospital Coventry & Warwickshire

Coventry, , United Kingdom

Site Status

Victoria Hospital

Kirkcaldy, , United Kingdom

Site Status

St Johns Hospital, Livingston

Livingston, , United Kingdom

Site Status

Royal Preston Hospital

Preston, , United Kingdom

Site Status

Countries

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Albania Austria Belgium Czechia Denmark Finland France Greece Hungary Italy Malta Norway Poland Romania Serbia Spain Turkey (Türkiye) United Kingdom

References

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Reed MJ, Karuranga S, Kearns D, Alawiye S, Clarke B, Mockel M, Karamercan M, Janssens K, Riesgo LG, Torrecilla FM, Golea A, Fernandez Cejas JA, Lupan-Muresan EM, Zaimi E, Nuernberger A, Rennet O, Skjaerbaek C, Polyzogopoulou E, Imecz J, Groff P, Camilleri R, Cimpoesu D, Jovic M, Miro O, Anderson R, Laribi S; SEED investigators. Management of syncope in the Emergency Department: a European prospective cohort study (SEED). Eur J Emerg Med. 2024 Apr 1;31(2):136-146. doi: 10.1097/MEJ.0000000000001101. Epub 2023 Nov 27.

Reference Type DERIVED
PMID: 38015745 (View on PubMed)

Other Identifiers

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AC22033

Identifier Type: -

Identifier Source: org_study_id

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