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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05571254
Acronym
SEED
Enrollment
952
Registered
2022-10-07
Start date
2022-09-12
Completion date
2022-12-02
Last updated
2023-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Syncope

Keywords

syncope, transient loss of consciousness, emergency department

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.

Interventions

OTHERData 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.

Sponsors

NHS Lothian
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Participant ageAdmissionParticipant age
Participant genderAdmissionParticipant gender
Mode of arrivalAdmissionMode of arrival
Referral sourceAdmissionReferral source
Presence of any European Society of Cardiology (ESC) syncope high-risk history featuresAdmissionWhich European Society of Cardiology syncope high-risk history features are present
ESC high-risk 'past medical history' featuresAdmissionWhich European Society of Cardiology syncope high-risk 'past medical history' features are present
Other medical comorbiditiesAdmissionOther medical comorbidities
Rockwood Clinical Frailty Scale scoreAdmissionRockwood Clinical Frailty Scale is a well validated score ranging from 1 (Very Fit) to 9 (Terminally Ill) with defined descriptions for each category.
ESC high risk 'physical examination' factorsAdmissionESC high risk 'physical examination' factors
Blood pressure (BP) on admissionAdmissionFirst Blood pressure (BP) measure in the Emergency Department in mmHg
Pulse rate on admissionAdmissionFirst pulse rate measured in the Emergency Department in beats per minute
Lying/standing systolic BP difference on admissionAdmissionFirst lying/standing systolic BP difference measured in the Emergency Department in mmHg
Number of participants with abnormal Electrocardiogram (ECG) readingsAdmissionNumber of participants with abnormal ECG readings
Troponin levelsAdmissionTroponin levels
D-dimer levelsAdmissionD-dimer levels
Copeptin levelsAdmissionCopeptin levels
Natriuretic peptides levelsAdmissionNatriuretic peptides levels
ED clinician diagnosisAdmissionED clinician diagnosis - descriptive
Patient destinationAdmissionDescriptive 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
Reason(s) for admissionAdmissionReason(s) for admission
Whether driving and occupation advice givenAdmissionWhether driving and occupation advice given
Status at discharge from hospital30 daysStatus at discharge from hospital
Length of hospital stay in days30 daysLength of hospital stay in days
Hospital discharge diagnosis30 daysHospital discharge diagnosis

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026