NCT Number: NCT05571254
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.
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Notify Me18 year and older
All sexes
Observational
Regional Hospital Durres, Durrës, Albania
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Admission
Participant age
Time frame: Admission
Participant gender
Time frame: Admission
Mode of arrival
Time frame: Admission
Referral source
Time frame: Admission
Which European Society of Cardiology syncope high-risk history features are present
Time frame: Admission
Which European Society of Cardiology syncope high-risk 'past medical history' features are present
Time frame: Admission
Other medical comorbidities
Time frame: Admission
Rockwood Clinical Frailty Scale is a well validated score ranging from 1 (Very Fit) to 9 (Terminally Ill) with defined descriptions for each category.
Time frame: Admission
ESC high risk 'physical examination' factors
Time frame: Admission
First Blood pressure (BP) measure in the Emergency Department in mmHg
Time frame: Admission
First pulse rate measured in the Emergency Department in beats per minute
Time frame: Admission
First lying/standing systolic BP difference measured in the Emergency Department in mmHg
Time frame: Admission
Number of participants with abnormal ECG readings
Time frame: Admission
Troponin levels
Time frame: Admission
D-dimer levels
Time frame: Admission
Copeptin levels
Time frame: Admission
Natriuretic peptides levels
Time frame: Admission
ED clinician diagnosis - descriptive
Time frame: Admission
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
Time frame: Admission
Reason(s) for admission
Time frame: Admission
Whether driving and occupation advice given
Time frame: 30 days
Status at discharge from hospital
Time frame: 30 days
Length of hospital stay in days
Time frame: 30 days
Hospital discharge diagnosis
NHS Lothian
Other Gov
The Management of Transient Loss of Consciousness (TLOC) and Suspected Syncope in European Emergency Departments: a Prospective Cohort Study
Acronym: SEED
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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