Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000475448
Ethics application status
Approved
Date submitted
19/07/2007
Date registered
21/09/2007
Date last updated
21/04/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Does point of care troponin testing speed up care of cardiac patients in emergency?
Scientific title
A randomized controlled trial of point of care troponin estimation vs in-lab methods to reduce length of stay in Emergency Department cardiac patients.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Possible Acute Coronary Syndrome in emergency patients 2179 0
Possible Acute Coronary Syndrome in emergency patients 2350 0
Condition category
Condition code
Cardiovascular 2274 2274 0 0
Other cardiovascular diseases
Cardiovascular 2456 2456 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Point of care troponin testing will be made available on some weeks.On other weeks the point of care troponin machine will be unavailable.The availability of the machine represents the intervention and the weeks that it is available will determined by computer generated randomization prior to the study and then concealed until the monday morning at the beginning of each week.At that time after opening that weeks allocation the machine will either be made available for use( which may save time for patients or not) or withdrawn for one week. If the machine is withdrawn for that week the clinical staff will be forced to use usual (laboratory bench-top methods) of testing troponin.The expected duration of the trial is 3 months assuming adequate numbers to power the study (150 in each arm)are recruited.
Intervention code [1] 1948 0
Diagnosis / Prognosis
Intervention code [2] 2072 0
Diagnosis / Prognosis
Comparator / control treatment
Control will be non availability of point of care, ie use usual in-lab methods. In lab methods means measuring the troponin level with a beckman coulter troponin assay system in the hospital laboratory
Control group
Active

Outcomes
Primary outcome [1] 3279 0
Reduced Length of Stay in the emergency department
Timepoint [1] 3279 0
measured from time of arrival to patient departure from emergency Department
Primary outcome [2] 3356 0
Reduced Length of Stay in the emergency department
Timepoint [2] 3356 0
measured from time of arrival to patient departure from emergency Department
Secondary outcome [1] 5461 0
The primary analysis will be intention to treat, however it is intended to perform a secondary efficacy analysis which may demonstrate that the machines save time if not always actually used. This is because there will not be mandatory use of the intervention and staff may choose not to use it.
Timepoint [1] 5461 0
measured immediately on discharge

Eligibility
Key inclusion criteria
All patients presenting to emergency with possible acute coronary syndrome
Minimum age
25 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.patients with acute elevation of the ess to tee segment of their electrocardiogram 2.patients arriving with known elevated troponin.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All consecutive eligible patients with possible coronary syndrome will be enrolled. Diagnostic test (i.e. lab vs point of care) will be assigned according to randomisation scheme for that week.This weill be by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomization of weeks will determine when point of care machine (intervention) will be used; during control weeks the point of care machine will be removed and usual lab methods (control) will be used
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/11/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2540 0
Government body
Name [1] 2540 0
NSW Department of Health
Country [1] 2540 0
Australia
Primary sponsor type
Individual
Name
Conrad Loten
Address
Dept of Emergency Medicine
John Hunter Hospital
Country
Australia
Secondary sponsor category [1] 2298 0
Individual
Name [1] 2298 0
John Attia
Address [1] 2298 0
Dept of General Medicine
John Hunter Hospital
Country [1] 2298 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4457 0
Hunter New England Health Ethics Committee
Ethics committee address [1] 4457 0
Ethics committee country [1] 4457 0
Australia
Date submitted for ethics approval [1] 4457 0
Approval date [1] 4457 0
21/06/2007
Ethics approval number [1] 4457 0
07/06/20/5.05

Summary
Brief summary
A randomized comparison of two types of troponin testing for ED patients.Currently ED patients with possible coronary syndromes wait significant times to be "cleared " or declared low enough risk for stress testing or discharge. One component of this wait is the time for troponin results to become available which may be reduced by using bedside or point of care(POC) tests.This could result in acute ED bed space being more efficiently utilized.Many other factors however may affect the speed of patient flow and a controlled trial will help to quantify this.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27711 0
Address 27711 0
Country 27711 0
Phone 27711 0
Fax 27711 0
Email 27711 0
Contact person for public queries
Name 11086 0
Conrad Loten
Address 11086 0
Division of Emegency Medicine
John Hunter Hospital
Hunter New England Health
Lookout road
New Lambton2305
PO Box 91
Waratah NSW 2298
Country 11086 0
Australia
Phone 11086 0
+61 2 49213000
Fax 11086 0
Email 11086 0
[email protected]
Contact person for scientific queries
Name 2014 0
Conrad Loten
Address 2014 0
Division of Emegency Medicine
John Hunter Hospital
Hunter New England Health
Lookout road
New Lambton2305
PO Box 91
Waratah NSW 2298
Country 2014 0
Australia
Phone 2014 0
+61 2 49213000
Fax 2014 0
Email 2014 0
[email protected]

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.