Clinical trial NCT05571254: The Management of Transient Loss of Consciousness and Suspected Syncope in European Emergency Departments
Official title: The Management of Transient Loss of Consciousness (TLOC) and Suspected Syncope in European Emergency Departments: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Syncope
Keywords: syncope
transient loss of consciousness
emergency department
Lead sponsor: NHS Lothian
Sponsor class: OTHER_GOV
First posted: 2022-10-07
Enrollment: 952
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Participant age
timeFrame: Admission
measure: Participant gender
timeFrame: Admission
measure: Mode of arrival
timeFrame: Admission
measure: Referral source
timeFrame: Admission
measure: Presence of any European Society of Cardiology (ESC) syncope high-risk history features
timeFrame: Admission
measure: ESC high-risk 'past medical history' features
timeFrame: Admission
measure: Other medical comorbidities
timeFrame: Admission
measure: Rockwood Clinical Frailty Scale score
timeFrame: Admission
measure: ESC high risk 'physical examination' factors
timeFrame: Admission
measure: Blood pressure (BP) on admission
timeFrame: Admission
measure: Pulse rate on admission
timeFrame: Admission
measure: Lying/standing systolic BP difference on admission
timeFrame: Admission
measure: Number of participants with abnormal Electrocardiogram (ECG) readings
timeFrame: Admission
measure: Troponin levels
timeFrame: Admission
measure: D-dimer levels
timeFrame: Admission
measure: Copeptin levels
timeFrame: Admission
measure: Natriuretic peptides levels
timeFrame: Admission
measure: ED clinician diagnosis
timeFrame: Admission
measure: Patient destination
timeFrame: Admission
measure: Reason(s) for admission
timeFrame: Admission
measure: Whether driving and occupation advice given
timeFrame: Admission
measure: Status at discharge from hospital
timeFrame: 30 days
measure: Length of hospital stay in days
timeFrame: 30 days
measure: Hospital discharge diagnosis
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Durres
country: Albania
facility: Regional Hospital Durres
city: Elbasan
country: Albania
facility: Regional Hospital Centre "Xh. Kongoli" Elbasan
city: Sarande
country: Albania
facility: Spitali "Petro Nako" Sarandra
city: Shkodra
country: Albania
facility: Regional Hospital Shkoder
city: Tirana
country: Albania
facility: University Hospital Centre "Mother Theresa" Tirana
city: Vienna
country: Austria
facility: Allgemeines Krankenhaus der Stadt Wien/ Universitätskliniken
city: Vienna
country: Austria
facility: Klinik Donaustadt
city: Brugge
country: Belgium
facility: AZ Sint Jan Brugge
city: Eeklo
country: Belgium
facility: AZ Alma Eeklo
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Lier
country: Belgium
facility: Heilig Hartziekenhuis Lier
city: Králová
country: Czechia
facility: University Hospital Hradec Králové
city: Praha
country: Czechia
facility: University Hospital Královské Vinohrady
city: Herning
country: Denmark
facility: Regionshospitalet Gødstrup
city: Hillerød
country: Denmark
facility: Nordsjællands Hospital
city: Randers
country: Denmark
facility: Regionshospitalet Randers
city: Roskilde
country: Denmark
facility: Sjællands Universitetshospital
city: Vildbjerg
country: Denmark
facility: Regionshospitalet Midt
city: Helsinki
country: Finland
facility: Kanta-Häme Central Hospital
city: Besançon
country: France
facility: CHU Besançon
city: Caen
country: France
facility: CHU Caen
city: Clermont-Ferrand
country: France
facility: CHU Clermond-Ferrand
city: Lyon
country: France
facility: Medipole
city: Tours
country: France
facility: CHU Tours
city: Athens
country: Greece
facility: University General Hospital ATTIKON
city: Heraklion
country: Greece
facility: General Hospital Venizeleio
city: Thessaloníki
country: Greece
facility: AHEPA Univesrity General Hospital of Thessaloniki
city: Budapest
country: Hungary
facility: Semmelweis University Department of Emergency Medicine
city: Bologna
country: Italy
facility: ED Azienda Ospedaliera Universitaria di Bologna (Sant'Orsola Hospital)
city: Catania
country: Italy
facility: ED Azienda Ospedaliera-universitaria di Catania (San Marco Hospital)
city: Firenze
country: Italy
facility: ED Azienda USL Toscana Centro, Firenze (San Giovanni di Dio Hospital)
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia (Santa Maria Della Misericordia Hospital)
city: Verona
country: Italy
facility: ED Azienda Ospedaliera-Universitaria integrata (Borgo Trento Hospital)
city: Birkirkara
country: Malta
facility: Mater Dei Hospital
city: Victoria
country: Malta
facility: Gozo General Hospital
city: Trondheim
country: Norway
facility: St. Olav's University Hospital
city: Wrocław
country: Poland
facility: Wroclaw University Hospital
city: Cluj-Napoca
country: Romania
facility: Cluj Napoca County Emergency Clinical Hospital
city: Iaşi
country: Romania
facility: Saint Spiridon County Hospital
city: Belgrad
country: Serbia
facility: Emergency Center Belgrade, Clinical Centre Belgade
city: Niš
country: Serbia
facility: Clinical Centre of Niš
city: Zaječar
country: Serbia
facility: Emergency Department Zaječar, Health Center Zaječar
city: Alicante
country: Spain
facility: Hospital Dr. Balmis
city: Barcelona
country: Spain
facility: Hospital clinic Barcelona
city: Barcelona
country: Spain
facility: Hospital de Terrassa
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Barcelona
country: Spain
facility: Hospital Universitari de Vic
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty Department of Emergency Medicine
city: Ankara
country: Turkey
facility: Medical Science University Ankara Education and Research Hospital Department of Emergency Medicine
city: Karaman
country: Turkey
facility: Karamanoglu Mehmetbey University Karaman Education and Research Hospital Department of Emergency Medicine
city: Konya
country: Turkey
facility: Necmettin Erbakan University Medical Faculty Department of Emergency Medicine
city: Şanlıurfa
country: Turkey
facility: Medical Science University Sanliurfa Mehmet Akif Inan Education and Research Hospital Department of Emergency Medicine
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
state: Midlothian
city: Coventry
country: United Kingdom
facility: University Hospital Coventry & Warwickshire
city: Kirkcaldy
country: United Kingdom
facility: Victoria Hospital
city: Livingston
country: United Kingdom
facility: St Johns Hospital, Livingston
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
Study officials:
affiliation: University of Edinburgh
name: Matt Reed
role: STUDY_CHAIR
References: