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Trial registered on ANZCTR
Registration number
ACTRN12620000595910
Ethics application status
Approved
Date submitted
24/04/2020
Date registered
22/05/2020
Date last updated
7/04/2024
Date data sharing statement initially provided
22/05/2020
Date results provided
7/04/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Australian and New Zealand Multicenter trial of Extended (6-8 hours) Non-Ischemic Heart Preservation (NIHP) of Donor Hearts for Transplantation
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Scientific title
Australian and New Zealand Multicenter trial of Extended (6-8 hours) Non-Ischemic Heart Preservation (NIHP) using the XVIVO heart preservation system of Donor Hearts for Transplantation
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Secondary ID [1]
300930
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Nil
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Universal Trial Number (UTN)
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Trial acronym
ANZ-NIHP
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Linked study record
n/a
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Health condition
Health condition(s) or problem(s) studied:
Heart Transplant
316908
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Chronic Heart Failure
316909
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Condition category
Condition code
Surgery
315085
315085
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0
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Other surgery
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Cardiovascular
315473
315473
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Brief name: XVIVO Heart Box/Preservation System.
The XVIVO Heart Box is a general-purpose donor-organ preservation/transport system. It is a non-dedicated system designed to support and maintain any donated organ (e.g., heart, kidney, liver) during transport from the donor to the receiving hospital where the organ will be transplanted into the recipient.
This system will provide technical support functions to keep the organ in as near-physiologic state as possible.
The XVIVO Heart Box/Preservation System consists of three separate devices:
- XVIVO Heart Box (re-usable)
- XVIVO Heart Disposable (single use)
- Supplemented XVIVO Heart Solution (single use)
The heart box is the device controlling the preservation system. The container, organ transport components include the 1) XVIVO Heart Box and 2) XVIVO Heart Disposable. A sterile disposable kit is placed into the heart box and tubes are fitted to the pump and clamp unit in the box. The connectors for gas, temperature and pressure sensors, integrated in the disposable kit, are connected to the box. The disposable reservoir kit is filled with perfusion solution from bags with the sterile heart solution, washed red blood cells and additives. The donor heart is attached to the heart cannula and submerged in the perfusion solution. The temperature of the perfusion solution, the CO2/O2 gas flow supplied to the perfusion solution and the pressure in the coronary arteries are controlled by the heart box during the transportation.
Donor Organ Preservation Solution consists of 1) XVIVO Heart Solution (XHS) and 2) XVIVO Heart Solution Supplement (XHSS). This is a sterile fluid used for hypothermic flushing, transport, and storage of donor organs (e.g., kidney, liver, heart, and pancreas) for transplant. The solution is intended to maintain organ viability until the organ can be implanted in the recipient. After application, this device cannot be reused.
The XVIVO Heart Box will be primed by the procuring surgeon and perfusionist from the transplant recipient hospital, in a controlled environment such as an operating room, pump room or operative prep room. The procuring surgeon will place the donor heart into the XVIVO Heart Box system. The Perfusionist will then travel with the donor heart inside the XVIVO Heart Box system from the donor hospital to the recipient hospital.
The XVIVO Heart Box will be utilised to preserve 36 donor hearts in total. In the initial phase of the trial, 12 donor hearts will be procured and transported with the NIHP method with less than 6 hours of anticipated ischemic time (standard NIHP). The remaining 24 donor hearts will be a projected ischemic time of 6-8 hours (extended NHIP).
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Intervention code [1]
317243
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Treatment: Devices
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Death as determined by prospective assessment, tests and medical records
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Assessment method [1]
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Timepoint [1]
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30 days post transplant
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Primary outcome [2]
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Primary graft dysfunction (moderate or severe) (according to Kobashigawa et al 2014) as determined by prospective assessment, tests and medical records,
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Assessment method [2]
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Timepoint [2]
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30 days post transplant
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Primary outcome [3]
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Re-transplantation as determined by prospective assessment, tests and medical records,
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Assessment method [3]
323718
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Timepoint [3]
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30 days post transplant
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Secondary outcome [1]
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• ICU length of stay as determined by prospective assessment, tests and medical records
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Assessment method [1]
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Timepoint [1]
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12 months post transplant
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Secondary outcome [2]
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• Incidence of acute cellular rejection (ACR) and antibody mediated rejection (AMR) as determined by prospective assessment, tests and medical records
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Assessment method [2]
382870
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Timepoint [2]
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12 months post transplant
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Secondary outcome [3]
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• Graft function as determined by prospective assessment, tests and medical records.
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Assessment method [3]
382871
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Timepoint [3]
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12 months post transplant
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Secondary outcome [4]
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• Incidence of cardiac allograft vasculopathy (CAV) as determined by prospective assessment, tests and medical records.
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Assessment method [4]
382872
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Timepoint [4]
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12 months post transplant
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Secondary outcome [5]
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• Re-transplantation as determined by prospective assessment, tests and medical records.
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Assessment method [5]
382873
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Timepoint [5]
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12 months post transplant
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Secondary outcome [6]
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• Arrhythmias as determined by prospective assessment, tests and medical records.
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Assessment method [6]
382874
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Timepoint [6]
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12 months post transplant
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Secondary outcome [7]
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• Graft function as determined by prospective assessment, tests and medical records.
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Assessment method [7]
382875
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Timepoint [7]
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12 months post transplant
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Secondary outcome [8]
382876
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• Need for permanent pacemaker (PPM) as determined by prospective assessment, tests and medical records.
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Assessment method [8]
382876
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Timepoint [8]
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12 months post transplant
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Secondary outcome [9]
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• Incidence of serious adverse events (SAEs; need for post-operative mechanical support, dialysis, ICU length of stay, ventilation) as determined by prospective assessment, tests and medical records.
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Assessment method [9]
382877
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Timepoint [9]
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12 months post transplant
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Eligibility
Key inclusion criteria
Donor Inclusion criteria:
• Age less than or equal to 60 years
• Accepted as heart donor by the transplant team
• Weight 30kg or greater
• Donor brain death
Recipient Inclusion criteria:
• Adult recipient - Aged 18 years and over as dictated by the local transplant program
• Paediatric recipient – Paediatric patients: aged 2-17 years AND must weigh 15 kgs or greater (i.e. if they satisfy the age criteria they must also be greater than 15 kg)
• Patients listed for heart transplantation for any indication including those with mechanical circulatory support and congenital heart disease.
• The anticipated ischemic time of less than 6 hours for the first 12 hearts (2 per centre) in the trial followed by 6-8 hours for the remaining 24 hearts.
• Signed informed consent form
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Minimum age
2
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Donor Exclusion criteria:
• DCD hearts
Recipient Exclusion criteria:
• Previous solid organ transplantation
• Patients with renal dysfunction to the degree that the transplant center is planning
combined heart/renal transplant (patients with lesser degrees of renal dysfunction will not be
excluded)
• Coagulopathy due to known hepatic disease or heparin induced thrombocytopenia
• Sepsis syndrome but positive blood culture and on microorganism speci c antimicrobial included
• Incompatible blood group
• Unable to understand the information provided during the informed consent procedure
• Combined organ transplantation candidates
• Patient already consented for another transplant related intervention study
• Patients under pre-transplant desensitisation protocol
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
n/a
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
n/a
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Data analysis will be performed by a trained statistician. To provide an overall estimate of treatment effect, data will be pooled across study centres. Distributions of continuous variables will be assessed for normality and reported (for each time point) as mean ± standard deviation (SD) for parametric data and median (interquartile range or minimum, maximum) for non-parametric data. Categorical variables will be reported using frequencies and percentages.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/06/2020
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Actual
2/12/2020
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Date of last participant enrolment
Anticipated
31/05/2022
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Actual
12/12/2022
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Date of last data collection
Anticipated
1/06/2023
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Actual
16/10/2023
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Sample size
Target
36
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Accrual to date
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Final
36
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Recruitment in Australia
Recruitment state(s)
NSW,WA,VIC
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Recruitment hospital [1]
16261
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The Alfred - Melbourne
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Recruitment hospital [2]
16262
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Fiona Stanley Hospital - Murdoch
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Recruitment hospital [3]
16263
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St Vincent's Hospital (Darlinghurst) - Darlinghurst
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Recruitment hospital [4]
16265
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The Royal Childrens Hospital - Parkville
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Recruitment postcode(s) [1]
29807
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
29805
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3004 - Melbourne
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Recruitment postcode(s) [3]
29809
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3052 - Parkville
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Recruitment postcode(s) [4]
29806
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
22463
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New Zealand
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State/province [1]
22463
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Auckland
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Funding & Sponsors
Funding source category [1]
305376
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Commercial sector/Industry
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Name [1]
305376
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XVIVO Perfusion AB
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Address [1]
305376
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Mässans Gata 10
412 51 Göteborg
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Country [1]
305376
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Sweden
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Primary sponsor type
Hospital
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Name
Alfred Health
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Address
Alfred Health
55 Commercial Road
Melbourne VIC 3004
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Country
Australia
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Secondary sponsor category [1]
305753
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None
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Name [1]
305753
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Address [1]
305753
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Country [1]
305753
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
305706
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The Alfred Ethics Committee
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Ethics committee address [1]
305706
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Alfred Health 55 Commercial Rd Melbourne VIC 3004
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Ethics committee country [1]
305706
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Australia
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Date submitted for ethics approval [1]
305706
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05/02/2020
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Approval date [1]
305706
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06/10/2020
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Ethics approval number [1]
305706
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Ethics committee name [2]
312868
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Northern A Health and Disability Ethics Committee
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Ethics committee address [2]
312868
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Health and Disability Ethics Committees Ministry of Health 133 Molesworth Street PO Box 5013 Wellington 6011
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Ethics committee country [2]
312868
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New Zealand
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Date submitted for ethics approval [2]
312868
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Approval date [2]
312868
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10/02/2022
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Ethics approval number [2]
312868
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Ethics 21/NTB/123
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Ethics committee name [3]
312869
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The Royal Children’s Hospital Melbourne Human Research Ethics Committee
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Ethics committee address [3]
312869
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The Royal Children's Hospital Melbourne 50 Flemington Road Parkville Victoria 3052
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Ethics committee country [3]
312869
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Australia
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Date submitted for ethics approval [3]
312869
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Approval date [3]
312869
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25/11/2021
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Ethics approval number [3]
312869
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HREC/78250/RCHM-2021
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Summary
Brief summary
The time from when a heart is removed from a brain dead organ donor and transplanted into a recipient is known as the ischemic time. This is a critical period of time since the donor heart is not receiving any blood supply, oxygen or nutrition and if the ischemic time becomes prolonged (beyond approximately 4 to 6 hours), the heart may be damaged to the point that it does not work well in the recipient (known as primary graft dysfunction). For the last 50 years of heart transplantation, transportation of the heart during the ischemic time involves stopping the heart by paralysing it chemically and then putting it in ice slush to cool it down and reduce its energy requirements, a technique known as cold static storage (CSS). Recent advances in donor heart preservation have led to the development of a mechanical perfusion system called non-ischemic heart preservation (NIHP). With this system, during the ischemic time, the heart can be continuously perfused with a solution containing hormones, oxygen and some nutrition. Protecting the donor heart using NIHP substantially increases the ischemic time while minimizing the risk of primary graft dysfunction. The aim of the current trial is to investigate the effectiveness of NIHP to increase the ischemic time of donor hearts to 6 to 8 hours. Findings from this study may demonstrate that NIHP is beneficial in preventing primary graft failure. Additionally, countries the size of Australia and New Zealand where donor hearts are often declined because the ischemic time is unacceptably long, NIHP of the donor heart may allow longer ischemic times and hence increase donor heart availability.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
101302
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Prof David McGiffin
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Address
101302
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Alfred Health
55 Commercial Road
Melbourne VIC 3004
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Country
101302
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Australia
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Phone
101302
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+61390762156
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Fax
101302
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Email
101302
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d.mcgiffin@alfred.org.au
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Contact person for public queries
Name
101303
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Christina Kure
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Address
101303
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Alfred Health
55 Commercial Road
Melbourne VIC 3004
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Country
101303
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Australia
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Phone
101303
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+61390763621
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Fax
101303
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Email
101303
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c.kure@alfred.org.au
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Contact person for scientific queries
Name
101304
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David Kaye
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Address
101304
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Alfred Health
55 Commercial Road
Melbourne VIC 3004
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Country
101304
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Australia
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Phone
101304
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+61390762157
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Fax
101304
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Email
101304
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D.Kaye@alfred.org.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Statistical analysis plan
c.kure@alfred.org.au
Ethical approval
c.kure@alfred.org.au
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
McGiffin DC, Kure CE, Macdonald PS, Jansz PC, Emma...
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Documents added automatically
No additional documents have been identified.
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