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Trial registered on ANZCTR


Registration number
ACTRN12608000165381
Ethics application status
Approved
Date submitted
2/04/2008
Date registered
4/04/2008
Date last updated
7/04/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Detecting injury to the heart after emergency orthopaedic surgery by means of a blood test (called Troponin I) and determining if care by the cardiology unit can improve mortality at one year compared to usual care
Scientific title
Troponin rise after emergency orthopaedic-geriatric surgery randomised to standard care versus cardiology care and its associaton with one year mortality
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial injury 2991 0
Condition category
Condition code
Cardiovascular 3142 3142 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All recruited patients will have troponin blood tests and electrocardiographs (ECGs) done on post-operative days 1,2 and 3. Patients with a post-operative troponin rise will then be randomised to either standard care or cardiology care (the intervention). The cardiology care protocol involves a "total package" of care. This involves transfer to the coronary care unit for 24hours, review by a cardiologist and consideration for catheterisation if symptomatic. If not for catheterisation or if asymptomatic cardiology treatment will involve medical management with aspirin, beta blocker, statin +/- Angiotensin Converting Enzyme (ACE) inhibitor. All medications will be given orally with the dose and frequency at the discretion of the cardiologist. Duration of medication treatment will be for at least the duration of hospitalization with ongoing medication treatment at the discretion of the cardiologist. Patients randomised to coronary care will also have cardiac investigations including serial ECGs, chest x-ray, lipid profile, echocardiogram. All patients randomised to coronary care will also receive outpatient follow up by a cardiologist and a functional cardiac study (either dobutamine stress echocardiography or thallium stress test, only if they are a candidate for catheterisation in the future).
Intervention code [1] 2731 0
Early detection / Screening
Intervention code [2] 2732 0
Treatment: Drugs
Intervention code [3] 2733 0
Other interventions
Comparator / control treatment
Patients with a troponin rise who are randomised to standard care will continue to receive usual ward care from the orthopaedic-geriatric unit. The usual care for patients after an orthopaedic operation at The Northern Hospital is to be reviewed by both the orthopaedic and geriatric units for the duration of the hospital admission. Patients who develop cardiac symptoms will still be elligible for cardiology review (including coronary care) if the treating team feel it is appropriate as this is part of standard ward care for symptomatic patients (eg. chest pain, arrhythmia, haemodynamically unstable, cardiac arrest).
Control group
Active

Outcomes
Primary outcome [1] 4026 0
all cause mortality at one year
Timepoint [1] 4026 0
one year after randomisation
Secondary outcome [1] 6779 0
all cause mortaliy
Timepoint [1] 6779 0
in hospital and at 6 months after randomisation
Secondary outcome [2] 6780 0
cardiac events (eg.Myocardial infarction, ischaemia, heart failure, major arrhythmia, cardiac arrest)
Timepoint [2] 6780 0
in hospital, 6 months, 1 year
Secondary outcome [3] 6781 0
ECG changes and correlation with troponin rises
Timepoint [3] 6781 0
in hospital, 6 months, 1 year
Secondary outcome [4] 6782 0
functional status measured by barthels index
Timepoint [4] 6782 0
baseline, 6 months, 1 year
Secondary outcome [5] 6783 0
Investigations and medications ordered by the cardiologist in comparison to standard care
Timepoint [5] 6783 0
in hospital, 6 months, 1 year

Eligibility
Key inclusion criteria
Patients over 60 admited under the orthopaedic unit who undergo emergency surgery
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Elective surgery, die before surgery, admitted under a different unit, patients with an estimated mortality of less than 1 year (eg. terminal cancer), nursing home patients.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment using pre-sealed tamper-evident evelopes will be used to enrol subjects (pre-sealed by an individual not involved in the trial). Envelopes will be opened in order of patient recruitment and signed by two people.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A statistical program will be used to generate block randomisation with variable block sizes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
154
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 636 0
3076

Funding & Sponsors
Funding source category [1] 3256 0
Self funded/Unfunded
Name [1] 3256 0
Country [1] 3256 0
Australia
Primary sponsor type
Individual
Name
Dr Carol Chong
Address
The Northern Hospital
c/o Northern Clinical Research Centre
185 Cooper Street
Epping, 3076
Victoria
Country
Australia
Secondary sponsor category [1] 2910 0
None
Name [1] 2910 0
Address [1] 2910 0
Country [1] 2910 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5238 0
Northern Health
Ethics committee address [1] 5238 0
The Northern Hospital
185 Cooper Street
Epping, 3076
Victoria
Ethics committee country [1] 5238 0
Australia
Date submitted for ethics approval [1] 5238 0
Approval date [1] 5238 0
27/03/2008
Ethics approval number [1] 5238 0
06/08

Summary
Brief summary
This project will determine whether standard care or cardiology care improves survival for patients undergoing emergency orthopaedic-geriatric surgery with a troponin rise.
A pilot study conducted at The Northern Hospital in 2006 revealed that at one year mortality rate was 21% in this population and those with a troponin rise were more at risk of dying. Therefore, this RCT is proposed to see if cardiology care is any better than standard care to improve survival.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28487 0
Address 28487 0
Country 28487 0
Phone 28487 0
Fax 28487 0
Email 28487 0
Contact person for public queries
Name 11644 0
Dr Carol Chong
Address 11644 0
The Northern Hospital
c/o Northern Clinical Research Centre
185 Cooper Street
Epping, 3076
Victoria
Country 11644 0
Australia
Phone 11644 0
03 8405 2008
Fax 11644 0
Email 11644 0
[email protected]
Contact person for scientific queries
Name 2572 0
Dr Carol Chong
Address 2572 0
The Northern Hospital
c/o Northern Clinical Research Centre
185 Cooper Street
Epping, 3076
Victoria
Country 2572 0
Australia
Phone 2572 0
03 8405 2008
Fax 2572 0
Email 2572 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

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No documents have been uploaded by study researchers.

Documents added automatically
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