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

Syncope Clinical Trial

— SEED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05571254
• Other study ID #: AC22033
• Status: Completed
• Start date: September 12, 2022
• Est. completion date: December 2, 2022

Study information

• Verified date: September 2022
• Source: NHS Lothian
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 952
• Est. completion date: December 2, 2022
• Est. primary completion date: December 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Syncope
• Unconsciousness

Intervention

Other:
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
NHS Lothian

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant age	Participant age	Admission
Primary	Participant gender	Participant gender	Admission
Primary	Mode of arrival	Mode of arrival	Admission
Primary	Referral source	Referral source	Admission
Primary	Presence of any European Society of Cardiology (ESC) syncope high-risk history features	Which European Society of Cardiology syncope high-risk history features are present	Admission
Primary	ESC high-risk 'past medical history' features	Which European Society of Cardiology syncope high-risk 'past medical history' features are present	Admission
Primary	Other medical comorbidities	Other medical comorbidities	Admission
Primary	Rockwood Clinical Frailty Scale score	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
Primary	ESC high risk 'physical examination' factors	ESC high risk 'physical examination' factors	Admission
Primary	Blood pressure (BP) on admission	First Blood pressure (BP) measure in the Emergency Department in mmHg	Admission
Primary	Pulse rate on admission	First pulse rate measured in the Emergency Department in beats per minute	Admission
Primary	Lying/standing systolic BP difference on admission	First lying/standing systolic BP difference measured in the Emergency Department in mmHg	Admission
Primary	Number of participants with abnormal Electrocardiogram (ECG) readings	Number of participants with abnormal ECG readings	Admission
Primary	Troponin levels	Troponin levels	Admission
Primary	D-dimer levels	D-dimer levels	Admission
Primary	Copeptin levels	Copeptin levels	Admission
Primary	Natriuretic peptides levels	Natriuretic peptides levels	Admission
Primary	ED clinician diagnosis	ED clinician diagnosis - descriptive	Admission
Primary	Patient destination	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
Primary	Reason(s) for admission	Reason(s) for admission	Admission
Primary	Whether driving and occupation advice given	Whether driving and occupation advice given	Admission
Primary	Status at discharge from hospital	Status at discharge from hospital	30 days
Primary	Length of hospital stay in days	Length of hospital stay in days	30 days
Primary	Hospital discharge diagnosis	Hospital discharge diagnosis	30 days