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Trial registered on ANZCTR


Registration number
ACTRN12611001265965
Ethics application status
Approved
Date submitted
28/11/2011
Date registered
12/12/2011
Date last updated
14/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Remote Ischaemic Preconditioning for Protection in Vascular Surgery
Scientific title
Remote Ischaemic Preconditioning for Protection in Vascular Surgery as assessed by Cardiac Troponin T and Clinical Outcomes
Secondary ID [1] 273481 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Open Abdominal Aortic Aneurysm Repair (or other Intra-Abdominal Vascular Surgery Procedure) 279269 0
Endovascular Abdominal Aortic Aneurysm Repair 279270 0
Extra-Abdominal Bypass Graft Surgery 279271 0
Condition category
Condition code
Cardiovascular 279468 279468 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 279469 279469 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Remote Ischaemic Preconditioning (RIPC) Intervention: Three 5-min cycles of RIPC administered by a blood pressure cuff inflated to 20 mm Hg above systolic blood pressure around the non-dominant arm, with an intervening 5 min of reperfusion between each cycle, during which time the cuff is deflated. This entire 3 x 5 min protocol is to be administered 24 hours prior to surgery, as well as after induction of anaesthesia, immediately prior to the start of the surgical procedure. Therefore, two complete RIPC protocols (6 bouts of 5 min of ischaemia) prior to surgery will be administered.
Intervention code [1] 283798 0
Prevention
Intervention code [2] 283799 0
Treatment: Other
Comparator / control treatment
Control: Sham application of the blood pressure cuff with no inflation
Control group
Placebo

Outcomes
Primary outcome [1] 286031 0
Cardiac-related clinical adverse events including (but not limited to) myocardial infarction and arrhythmias. Clinical adverse events will be assessed by standard clinical assessments performed by the primary clinician caring for the patient. If an event is suspected (e.g. MI), standard clinical investigations will be ordered as per usual practice (e.g. for MI - ECG and cardiac Troponin T blood test). All adverse events will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) and they will be recorded by the study co-ordinator.
Timepoint [1] 286031 0
Clinical adverse events: Any time peri-operatively, until discharge.
Primary outcome [2] 286032 0
Cardiac Troponin T measured in plasma using a high-sensitivity assay.
Timepoint [2] 286032 0
Blood samples: 24 hours prior to surgery, immediately pre-surgery, 6, 12, 24, 48, 72, 96 and 120 post-surgery.
Secondary outcome [1] 295021 0
Renal-related clinical adverse events including (but not limited to) renal dialysis. Assessed as per cardiac-related adverse events.
Timepoint [1] 295021 0
Clinical adverse events: Any time peri-operatively, until discharge.
Secondary outcome [2] 295184 0
Creatinine, urea and electrolytes measured in plasma.
Timepoint [2] 295184 0
Blood samples: 24 hours prior to surgery, 24 and 48 hours post-surgery.

Eligibility
Key inclusion criteria
Patients due to undergo elective or urgent major vascular surgery at Dunedin Public Hospital (open AAA repair, EVAR, extra-abdominal bypass graft surgery).
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation created by computer software.
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
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3980 0
New Zealand
State/province [1] 3980 0
Otago

Funding & Sponsors
Funding source category [1] 284272 0
University
Name [1] 284272 0
University of Otago
Address [1] 284272 0
Department of Surgical Sciences
Dunedin School of Medicine
University of Otago
201 Great King Street
Dunedin 9016
Country [1] 284272 0
New Zealand
Primary sponsor type
Individual
Name
Andre van Rij
Address
Head of Department
Department of Surgical Sciences
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 283223 0
None
Name [1] 283223 0
Address [1] 283223 0
Country [1] 283223 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286231 0
Lower South Regional Ethics Committee
Ethics committee address [1] 286231 0
Ministry of Health
229 Moray Place
Dunedin 9016
Ethics committee country [1] 286231 0
New Zealand
Date submitted for ethics approval [1] 286231 0
Approval date [1] 286231 0
05/08/2011
Ethics approval number [1] 286231 0
LRS/11/07/024

Summary
Brief summary
Ischaemia-Reperfusion Injury is a specific type of tissue damage that unfortunately often occurs following major surgery, such as Vascular Surgery. A technique called Remote Ischaemic Preconditioning (RIPC) is known to provide protection to the heart and other tissues in such a setting. This technique involves interrupting the blood supply to a limb for a brief period, and it is simply performed by intermittently inflating a blood pressure cuff around the arm. There appear to be two phases of protection, early and late.

The aim of this project is therefore to investigate the potential of combining these two phases of protection by administering RIPC twice pre-surgery in a vascular surgery group. We hypothesize that this RIPC protocol will reduce the risk of cardiac and renal complications during and following surgery.
Trial website
Trial related presentations / publications
http://www.ncbi.nlm.nih.gov/pubmed/27075990
http://www.ncbi.nlm.nih.gov/pubmed/27102874

Thomas KN, Cotter JD, Williams MJ, van Rij AM. Repeated Episodes of Remote Ischemic Preconditioning for the Prevention of Myocardial Injury in Vascular Surgery. Vasc Endovascular Surg. 2016;50(3):140-6.

Thomas KN, Cotter JD, Williams MJ, van Rij AM. Diagnosis, Incidence, and Clinical Implications of Perioperative Myocardial Injury in Vascular Surgery. Vasc Endovascular Surg. 2016;50(4):247-55.
Public notes

Contacts
Principal investigator
Name 33449 0
Prof Andre van Rij
Address 33449 0
Department of Surgical Sciences Dunedin School of Medicine University of Otago PO Box 913 Dunedin 9054
Country 33449 0
New Zealand
Phone 33449 0
+64 3474 0999 ext 58835
Fax 33449 0
Email 33449 0
andre.vanrij@otago.ac.nz
Contact person for public queries
Name 16696 0
Prof Professor Andre van Rij
Address 16696 0
Department of Surgical Sciences
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin 9054
Country 16696 0
New Zealand
Phone 16696 0
+64 3474 0999 ext 58835
Fax 16696 0
Email 16696 0
andre.vanrij@otago.ac.nz
Contact person for scientific queries
Name 7624 0
Prof Professor Andre van Rij
Address 7624 0
Department of Surgical Sciences
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin 9054
Country 7624 0
New Zealand
Phone 7624 0
+64 3474 0999 ext 58835
Fax 7624 0
Email 7624 0
andre.vanrij@otago.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary