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

NCT05571254 | Completed

• 1 other identifier: AC22033
• Study Type: observational
• Target: 952
• Locations: 18 countries
• Sites: 57

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.

Conditions

Syncope

Keywords

syncope; transient loss of consciousness; emergency department

Outcome Measures

Primary Outcomes (24)

• Participant age

  Participant age

  Admission

• Participant gender

  Participant gender

  Admission

• Mode of arrival

  Mode of arrival

  Admission

• Referral source

  Referral source

  Admission

• 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

• ESC high-risk 'past medical history' features

  Which European Society of Cardiology syncope high-risk 'past medical history' features are present

  Admission

• Other medical comorbidities

  Other medical comorbidities

  Admission

• 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

• ESC high risk 'physical examination' factors

  ESC high risk 'physical examination' factors

  Admission

• Blood pressure (BP) on admission

  First Blood pressure (BP) measure in the Emergency Department in mmHg

  Admission

• Pulse rate on admission

  First pulse rate measured in the Emergency Department in beats per minute

  Admission

• Lying/standing systolic BP difference on admission

  First lying/standing systolic BP difference measured in the Emergency Department in mmHg

  Admission

• Number of participants with abnormal Electrocardiogram (ECG) readings

  Number of participants with abnormal ECG readings

  Admission

• Troponin levels

  Troponin levels

  Admission

• D-dimer levels

  D-dimer levels

  Admission

• Copeptin levels

  Copeptin levels

  Admission

• Natriuretic peptides levels

  Natriuretic peptides levels

  Admission

• ED clinician diagnosis

  ED clinician diagnosis - descriptive

  Admission

• 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

• Reason(s) for admission

  Reason(s) for admission

  Admission

• Whether driving and occupation advice given

  Whether driving and occupation advice given

  Admission

• Status at discharge from hospital

  Status at discharge from hospital

  30 days

• Length of hospital stay in days

  Length of hospital stay in days

  30 days

• Hospital discharge diagnosis

  Hospital discharge diagnosis

  30 days

Interventions

Data collection OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Lothian: lead

Study Sites (57)

Regional Hospital Durres

Durrës, Albania

Location

Regional Hospital Centre "Xh. Kongoli" Elbasan

Elbasan, Albania

Location

Spitali "Petro Nako" Sarandra

Sarandë, Albania

Location

Regional Hospital Shkoder

Shkodër, Albania

Location

University Hospital Centre "Mother Theresa" Tirana

Tirana, Albania

Location

Allgemeines Krankenhaus der Stadt Wien/ Universitätskliniken

Vienna, Austria

Location

Klinik Donaustadt

Vienna, Austria

Location

AZ Sint Jan Brugge

Bruges, Belgium

Location

AZ Alma Eeklo

Eeklo, Belgium

Location

Ghent University Hospital

Ghent, Belgium

Location

Heilig Hartziekenhuis Lier

Lier, Belgium

Location

University Hospital Hradec Králové

Králová, Czechia

Location

University Hospital Královské Vinohrady

Prague, Czechia

Location

Regionshospitalet Gødstrup

Herning, Denmark

Location

Nordsjællands Hospital

Hillerød, Denmark

Location

Regionshospitalet Randers

Randers, Denmark

Location

Sjællands Universitetshospital

Roskilde, Denmark

Location

Regionshospitalet Midt

Vildbjerg, Denmark

Location

Kanta-Häme Central Hospital

Helsinki, Finland

Location

CHU Besançon

Besançon, France

Location

CHU Caen

Caen, France

Location

CHU Clermond-Ferrand

Clermont-Ferrand, France

Location

Medipole

Lyon, France

Location

CHU Tours

Tours, France

Location

University General Hospital ATTIKON

Athens, Greece

Location

General Hospital Venizeleio

Heraklion, Greece

Location

AHEPA Univesrity General Hospital of Thessaloniki

Thessaloniki, Greece

Location

Semmelweis University Department of Emergency Medicine

Budapest, Hungary

Location

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

Bologna, Italy

Location

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

Catania, Italy

Location

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

Florence, Italy

Location

Azienda Ospedaliera di Perugia (Santa Maria Della Misericordia Hospital)

Perugia, Italy

Location

ED Azienda Ospedaliera-Universitaria integrata (Borgo Trento Hospital)

Verona, Italy

Location

Mater Dei Hospital

Birkirkara, Malta

Location

Gozo General Hospital

Victoria, Malta

Location

St. Olav's University Hospital

Trondheim, Norway

Location

Wroclaw University Hospital

Wroclaw, Poland

Location

Cluj Napoca County Emergency Clinical Hospital

Cluj-Napoca, Romania

Location

Saint Spiridon County Hospital

Iași, Romania

Location

Emergency Center Belgrade, Clinical Centre Belgade

Belgrade, Serbia

Location

Clinical Centre of Niš

Niš, Serbia

Location

Emergency Department Zaječar, Health Center Zaječar

Zaječar, Serbia

Location

Hospital Dr. Balmis

Alicante, Spain

Location

Hospital clinic Barcelona

Barcelona, Spain

Location

Hospital de Terrassa

Barcelona, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, Spain

Location

Hospital Universitari de Vic

Barcelona, Spain

Location

Gazi University Medical Faculty Department of Emergency Medicine

Ankara, Turkey (Türkiye)

Location

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

Ankara, Turkey (Türkiye)

Location

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

Karaman, Turkey (Türkiye)

Location

Necmettin Erbakan University Medical Faculty Department of Emergency Medicine

Konya, Turkey (Türkiye)

Location

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

Sanliurfa, Turkey (Türkiye)

Location

Royal Infirmary of Edinburgh

Edinburgh, Midlothian, EH16 4SA, United Kingdom

Location

University Hospital Coventry & Warwickshire

Coventry, United Kingdom

Location

Victoria Hospital

Kirkcaldy, United Kingdom

Location

St Johns Hospital, Livingston

Livingston, United Kingdom

Location

Royal Preston Hospital

Preston, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 38015745 DERIVED

MeSH Terms

Conditions

Syncope; Emergencies

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Matt Reed

  University of Edinburgh

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: October 7, 2022
• Study Start: September 12, 2022
• Primary Completion: December 2, 2022
• Study Completion: December 2, 2022
• Last Updated: March 23, 2023

Record last verified: 2022-09

Locations

NO (1); PL (1); DK (5); HU (1); BE (4); AU (2); CZ (2); FR (5); SE (3); MA (2); FI (1); ES (5); TU (5); GR (3); AL (5); GB (5); RO (2); IT (5)