Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000489897
Ethics application status
Approved
Date submitted
11/04/2012
Date registered
3/05/2012
Date last updated
21/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Using Brain-Natriuretic Peptide (blood test for heart failure) and the San Francisco Syncope Rule to reduce hospital admissions for fainting.
Scientific title
Adding the Brain-Natriuretic Peptide (BNP) blood test to the San Francisco Syncope Rule to reduce hospital admissions from the emergency department with syncope.
Secondary ID [1] 280275 0
Nil
Universal Trial Number (UTN)
Trial acronym
Syncope Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Syncope 286228 0
Condition category
Condition code
Neurological 286445 286445 0 0
Other neurological disorders
Public Health 286446 286446 0 0
Health service research
Cardiovascular 286646 286646 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
An additional 5ml of blood will be drawn with the initial blood taken for standard clinical managment during patients presentation to ED for syncope. If blood is not being taken for clinical care, patient will be asked if they wish to take part in the study and provide a blood sample. The blood will be tested for Brain-Natriuretic peptide levels using the Alere Triage machine. There will be no storage of blood, other than temporarily if the testing needs to be done at a later date.

Data will be collected using a standardised data collection form. Patients will be managed and discharged as determined by their treating clinician as per their clinical judgement - the trial blood sample will not be available to clinicians.

Patients will be recruited for 12 months with the aim for at least 450 patients.

Patients will be telephoned by research nurses at approximately 30 days post ED discharge and asked a series of standard questions regarding their health and investigations since ED discharge. Hospital summaries and results of investigations will be obtained by research staff.

The San Franciso Rule will be applied to the patient data retrospectively, there will be no change to patient care. The San Francisco Rule considers patients with an abnormal ECG, a complaint of shortness of breath, haematocrit less than 30%, systolic blood pressure less than 90 mm Hg or a history of congestive heart failure is at risk of an adverse outcome and should be admitted for futher investigation.
Intervention code [1] 284627 0
Not applicable
Comparator / control treatment
Standard clinical management of syncope, will be as deemed appropriate by the treating physician with no reference made to the San Francisco rule or the syncope research study.
Control group
Active

Outcomes
Primary outcome [1] 286892 0
Serious adverse outcome. Serious adverse outcome is defined as any of: Death, AMI, arrhythmia, pulmonary embolism, stroke, subarachnoid haemorhage, significant haemorrhage or any condition causing or likely to cause a return ED visit and hospitalisation for a related event.

Death will be determined from hospital records or the hospital morbidity system which is reguarly updated from the WA Births and Deaths Registry.

Myocardial Infarction: The definition will be any elevation of troponin or ECG change with an accompanying diagnosis and confirmed by the treating consultant.

Pulmonary Embolism: Determined by ventilation perfusion scanning, computed tomography (CT) of the chest or angiography or confirmed on autopsy.

Stroke: Determined by discharge diagnosis asssigned by treating consultant.

Subarachnoid haemorhage: Determined by discharge diagnosis asssigned by the treating consultant.

Significant Haemorrhage: Source of bleeding that required transfusion or other therapeutic intervention eg. iron infusion.

Arrhythmia:To be captured on monitoring and thought to have had a temporal relationship to the syncopal or near syncopal event. The treating consultant will determine whether there was a temporal relationship to the syncope event.

Representation to the ED resulting in hospital admission, with a condition that can be related back to the original syncopal event. This will be determined by the PI's.
Timepoint [1] 286892 0
Within 30 days of Emergency Department attendence
Secondary outcome [1] 296922 0
Nil
Timepoint [1] 296922 0
Nil

Eligibility
Key inclusion criteria
Patients presenting to Hospital Emergency Departments with “Collapse”, “Syncope” or “Faint” will be eligible for recruitment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients < 18 years old, pregnancy,altered mental state, alcohol or illicit drug-related loss of consciousness, a definite seizure or transient loss of consciousness caused by head trauma, inability to obtain consent, and likely inability to conduct follow-up (e.g. overseas visitors).

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/03/2012
Actual
7/03/2012
Date of last participant enrolment
Anticipated
Actual
24/11/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285049 0
Charities/Societies/Foundations
Name [1] 285049 0
Fremantle Hospital Medical Research Foundation
Country [1] 285049 0
Australia
Primary sponsor type
Individual
Name
Karen Shakespeare
Address
Fremantle Hospital Emeregency Medicine Research Unit
PO Box 480
Fremantle WA 6959
Country
Australia
Secondary sponsor category [1] 283913 0
Individual
Name [1] 283913 0
Yusuf Nagree
Address [1] 283913 0
Fremantle Hospital Emergency Medicine Research Unit
PO Box 480
Fremantle WA 6959
Country [1] 283913 0
Australia
Other collaborator category [1] 260715 0
Individual
Name [1] 260715 0
Stephen MacDonald
Address [1] 260715 0
Armadale Health Service
PO Box 460
Armadale WA 6992
Country [1] 260715 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287054 0
South Metropolitan Area Health Service HREC
Ethics committee address [1] 287054 0
Ethics committee country [1] 287054 0
Australia
Date submitted for ethics approval [1] 287054 0
Approval date [1] 287054 0
01/03/2012
Ethics approval number [1] 287054 0
12/01/2012

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34021 0
Mrs Karen Shakespeare
Address 34021 0
Fremantle Hospital Emergency Medicine Research Unit Fremantle Hospital PO Box 480 Fremantle WA 6959
Country 34021 0
Australia
Phone 34021 0
+61 08 9431 3733
Fax 34021 0
Email 34021 0
karen.shakespeare@health.wa.gov.au
Contact person for public queries
Name 17268 0
Karen Shakespeare
Address 17268 0
Fremantle Hospital Emergency Medicine Research Unit
Fremantle Hospital
PO Box 480
Fremantle WA 6959
Country 17268 0
Australia
Phone 17268 0
+61 08 9431 3733
Fax 17268 0
+61 08 9431 3073
Email 17268 0
karen.shakespeare@health.wa.gov.au
Contact person for scientific queries
Name 8196 0
Karen Shakespeare
Address 8196 0
Fremantle Hospital Emergency Medicine Research Unit
Fremantle Hospital
PO Box 480
Fremantle WA 6959
Country 8196 0
Australia
Phone 8196 0
+61 08 9431 3733
Fax 8196 0
+61 08 9431 3073
Email 8196 0
karen.shakespeare@health.wa.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.