NICE Guideline 'Red Flags' to Predict Serious Outcome After Transient Loss of Consciousness

Withdrawn

• Conditions: Syncope

• Registration Number: NCT01498471
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

This study is designed to evaluate the accuracy of the National Institute for Health and Clinical Excellence (NICE) guideline 'red flags' to identify patients at high risk of short term serious outcome when presenting in the emergency department (ED) with Transient Loss of Consciousness (TLoC). Red flags were defined as ECG abnormality, history or physical signs of heart failure, TLoC during exercise, family history of sudden cardiac death at an age \< 40 years and/or an inherited cardiac condition, new or unexplained breathlessness, heart murmur, absence of prodromal symptoms in any patient aged \> 65 years.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-20
• Study First Submitted QC: 2011-12-22
• Study First Posted: 2011-12-23
• Study Start: 2012-01
• Primary Completion: 2013-02
• Study Completion: 2014-02
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Adult patients (>= 16 years) with a complaint of TLoC

Exclusion Criteria

• Patients needing immediate treatment, with trauma related or drug or alcohol related TLoC were excluded, as well as patient with persistent altered level of consciousness, simple fall and drop attack

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
serious outcome	day 7	death, myocardial infarction, arrhythmias, pulmonary embolism, stroke or transient ischemic attack, subarachnoid or non traumatic cerebral haemorrhage, aortic dissection, new diagnosis of structural heart disease thought to be related to syncope, and significant haemorraghe or anemia requiring blood transfusion, readmission for similar symptoms related to the initial event and acute intervention during hospital admission

Secondary Outcome Measures

Name	Time	Method
serious outcome	1 year	death, myocardial infarction, arrhythmias, pulmonary embolism, stroke or transient ischemic attack, subarachnoid or non traumatic cerebral haemorrhage, aortic dissection, new diagnosis of structural heart disease thought to be related to syncope, and significant haemorraghe or anemia requiring blood transfusion, readmission for similar symptoms related to the initial event and acute intervention during hospital admission

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium