Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609001044213
Ethics application status
Not yet submitted
Date submitted
2/12/2009
Date registered
7/12/2009
Date last updated
10/07/2019
Date data sharing statement initially provided
10/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Remote ischaemic preconditioning in patients undergoing surgery for fractured neck of femur.
Scientific title
Remote ischaemic preconditioning for patients over 65 with fractured neck of femur as a technique to reduce peri-operative myocardial damage, determined by blood troponin markers.
Secondary ID [1] 1174 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peri-operative myocardial damage 252327 0
Condition category
Condition code
Cardiovascular 252514 252514 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Remote Ischaemic Preconditioning.

This will be applied to the non dominant arm (wherever possible) using an arterial tourniquet at a pressure of systolic blood pressure +40mmHg. The periods of ischaemia will be 5 minutes long, followed by a 5 minute 'washout' or 'rest' period. There will be a total of 3 such ischaemic cycles.

Patients assigned to this group will recieve 3 identical cycles as described above. The study design has 2 parallel groups, so participants in this group will not crossover to the sham inflation.
Intervention code [1] 255635 0
Treatment: Other
Comparator / control treatment
Comparitor: Sham inflation.

This will be applied to the non dominant arm (wherever possible). A pressure of 30mmHg of mercury will be applied for a period of 5 minutes. These periods will be for 5 minutes, separated by a 5 minute 'washout' or 'rest peroid. There will be a total of 3 such periods.

Patients assigned to this group will recieve 3 identical cycles as described above. The study design has 2 parallel groups, so participants in this group will not crossover to the ischaemic intervention.
Control group
Placebo

Outcomes
Primary outcome [1] 253401 0
Samples of participants blood will be analysed for serum troponin I levels (performed in a biochemical laboratory)
Timepoint [1] 253401 0
Day 1 post op
Day 2 post op
Primary outcome [2] 253402 0
Post operative electrocardiogram changes associated with ischaemia, infarction or new onset arrhythmias
Timepoint [2] 253402 0
Day 1 post op
Day 2 post op
Secondary outcome [1] 262487 0
Numbers of patients who present with major adverse cardiac events (acute coronary syndromes, myocardial infarction (fatal and non fatal), episodes of cardiac failure, death from cardiac causes, hospital admissions due to cardiac causes will be extracted from hospital databases/notes. The numbers of patients presenting with these events will be recorded in the study database
Timepoint [1] 262487 0
1 year post op

Eligibility
Key inclusion criteria
Patients (male / female, all ethnic groups) >65yrs who present to Middlemore Hospital with a fractured neck of femur
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if:
They do not consent, or are unable to consent to take part in the study.

They are already participating in another clinical trial.

Patients present with a second fracture and have previously been recruited to the study.

Patients have elevated pre-operative serum troponin I levels.

Patients are taking cyclsporin or K+ channel agents

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
trial was registered before newer work was published, suggesting this study would be futile
Date of first participant enrolment
Anticipated
1/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment outside Australia
Country [1] 2351 0
New Zealand
State/province [1] 2351 0

Funding & Sponsors
Funding source category [1] 256118 0
Government body
Name [1] 256118 0
Health Research Council (HRC) New Zealand
Country [1] 256118 0
New Zealand
Primary sponsor type
Government body
Name
HRC New Zealand
Address
Level 3, 110 Stanley Street, Auckland, 1010, New Zealand
Country
New Zealand
Secondary sponsor category [1] 251484 0
None
Name [1] 251484 0
Not applicable
Address [1] 251484 0
Country [1] 251484 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258212 0
Ethics committee address [1] 258212 0
Application is in progress, the next ethics comitte meeting is not untill Jan 2010, I am awaiting a decision from the ethics comittee.
Ethics committee country [1] 258212 0
Date submitted for ethics approval [1] 258212 0
20/12/2010
Approval date [1] 258212 0
Ethics approval number [1] 258212 0

Summary
Brief summary
This study will evaluate an innovative technique which may reduce the chance of older patients suffering heart attacks that occur around the time of surgery.

A technique called ‘remote ischaemic preconditioning’ will be used. This involves placing a special blood pressure cuff on the patient’s arm. After anaesthesia but before surgery starts, the cuff will inflate and deflate, briefly interrupting the blood supply. This process releases chemical ‘warning signals’ to the heart, making it less vulnerable to damage during a subsequent heart attack.

During a heart attack, heart muscle becomes damaged. Blood tests can measure how much heart muscle has been damaged. The success of the effects of remote ischaemic preconditioning will be measured by using these blood tests of heart damage.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30570 0
Address 30570 0
Country 30570 0
Phone 30570 0
Fax 30570 0
Email 30570 0
Contact person for public queries
Name 13817 0
Julian Dimech
Address 13817 0
Anaesthetic Department
Staff Centre Level 2
Middlemore hospital
Otahuhu 1640
Auckland
Country 13817 0
New Zealand
Phone 13817 0
+64 (0) 9 2760000
Fax 13817 0
Email 13817 0
[email protected]
Contact person for scientific queries
Name 4745 0
Julian Dimech
Address 4745 0
Anaesthetic Department
Staff Centre Level 2
Middlemore hospital
Otahuhu 1640
Auckland
Country 4745 0
New Zealand
Phone 4745 0
+64 (0) 9 2760000
Fax 4745 0
Email 4745 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.