Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001004358
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
24/07/2026
Date registered
Help: Date registered
14/08/2026
Date last updated
Help: Date last updated
14/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
14/08/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Hypothermic Oxygenated Perfusion (HOPE) in Donation after Circulatory Death (DCD) for Adult Heart Transplantation Patients
Scientific title
Clinical Outcomes of Hypothermic Oxygenated Perfusion (HOPE) in Donation after Circulatory Death (DCD) for Heart Transplantation Patients
Additional trial identifiers [1] 318006 0
Nil
Universal Trial Number (UTN)
Trial acronym
HOPE DCD
Related trial records

Health condition
Health condition(s) studied:
Heart failure 343005 0
Heart Transplantation 343088 0
Condition category
Condition code
Cardiovascular 339099 339099 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Cardiac hypothermic oxygenated machine perfusion (HOPE) including the XVIVO Heart Assist Transport (XHAT), its disposable unit XVIVO Heart Assist Transport Perfusion Set (XHATPS), and supplemented XVIVO heart solution.

Following procurement of a DCD donor heart, the heart will undergo ex vivo hypothermic oxygenated machine perfusion (HOPE) during preservation and transport. HOPE continuously circulates an oxygenated preservation solution through the donor heart at 8 degrees Celsius, with the aim of reducing ischaemic injury, maintaining myocardial viability, extending preservation time, and improving post-transplant graft function. The intervention is being evaluated as an alternative preservation strategy to prolonged normothermic machine perfusion currently used in Direct Procurement and Perfusion (DPP).

The XHAT will be operated by the heart transplant team with expertise in donor heart preservation this will include the 1) Cardiothoracic transplant surgeons experienced in DCD heart procurement and transplantation and 2) Perfusionists trained in the operation and management of ex vivo organ perfusion systems

All personnel involved will be appropriately credentialed and trained in the use of the HOPE preservation system and transplantation procedures. The HOPE system is already being used routinely in a DBD (donation after brain death) donor setting and the training is done regularly by those already credentialed with the aide of XVIVO using training kits and assisting during procurements.

Following DCD donor heart procurement, the donor heart is connected to the XHAT. The heart is perfused with oxygenated preservation solution at 8 degrees Celsius during transport to the transplant centre. The duration of HOPE will be 2 hours at minimum, and may exceed 8 hours if necessary.

The preserved donor heart is subsequently implanted into the recipient according to standard heart transplantation procedures.

The XHAT will be used once per donor heart during the period between procurement and transplantation. HOPE is applied continuously throughout the donor heart preservation and transport period.

The XHAT 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 XHAT system. The Perfusionist will then travel with the donor heart inside the XHAT system from the donor hospital to the recipient hospital.

The duration of perfusion will vary depending on the donor-to-recipient transport and implantation time, with the technique intended to facilitate preservation times longer than those achievable with conventional cold static storage.

As this is a device-based organ preservation intervention, adherence will be monitored through:
- Documentation of donor heart procurement and preservation procedures.
- Continuous monitoring and recording of perfusion parameters during HOPE.
- Review of device logs and perfusion records by the study team.
- Compliance with the study protocol and standard operating procedures for donor heart preservation and transplantation.
Intervention code [1] 334878 0
Treatment: Devices
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 346339 0
Mortality
Timepoint [1] 346339 0
30 days post transplant
Primary outcome [2] 346340 0
severe primary graft dysfunction (PGD)
Timepoint [2] 346340 0
30 days post transplant
Primary outcome [3] 346341 0
Re-transplantation
Timepoint [3] 346341 0
30 days post transplant
Secondary outcome [1] 465467 0
Incidence of biopsy verified acute cellular rejection (ACR)
Timepoint [1] 465467 0
12 months post transplant
Secondary outcome [2] 465468 0
Incidence of biopsy verified antibody mediated rejection (AMR)
Timepoint [2] 465468 0
12 months post transplant
Secondary outcome [3] 465469 0
Incidence of cardiac allograft vasculopathy (CAV)
Timepoint [3] 465469 0
12 months post transplant
Secondary outcome [4] 465470 0
Re-transplantation
Timepoint [4] 465470 0
12 months post transplant
Secondary outcome [5] 465471 0
Moderate PGD
Timepoint [5] 465471 0
12 months post transplant
Secondary outcome [6] 465472 0
Arrhythmias
Timepoint [6] 465472 0
12 months post transplant
Secondary outcome [7] 465473 0
Need for permanent pacemaker (PPM)
Timepoint [7] 465473 0
12 months post transplant
Secondary outcome [8] 465474 0
Need for post-operative mechanical support
Timepoint [8] 465474 0
12 months post transplant
Secondary outcome [9] 465475 0
Need for post-operative dialysis
Timepoint [9] 465475 0
12 months post transplant
Secondary outcome [10] 465476 0
Graft function using TTE (transthoracic echocardiogram) and cardiac magnetic resonance imaging (MRI)
Timepoint [10] 465476 0
12 months post transplant
Secondary outcome [11] 465477 0
Postoperative mechanical ventilation time
Timepoint [11] 465477 0
12 months post transplant
Secondary outcome [12] 465478 0
Incidence of serious adverse events (SAEs) – unexpected, and those with possible relation to XHAT.
Timepoint [12] 465478 0
12 months post transplant

Eligibility
Key inclusion criteria
Donor Inclusion Criteria:
- DCD donors aged < 50 years.


Recipient Inclusion Criteria:
- patients listed for heart transplantation for any indication including those supported by mechanical circulatory support excluding those supported by durable biventricular assist device
- Signed informed consent form
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Donor Exclusion criteria:
- Donation via DBD pathway
- Inability to administer antemortem heparin due to donor hospital policy

Recipient Exclusion criteria recipient
- Previous solid organ transplantation
- Complex congenital heart disease
- Supported on durable biventricular assist device
- Coagulopathy due to known hepatic disease or heparin induced thrombocytopenia
- Sepsis
- 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 desensitization protocol
- If the transplant team felt operative risk is excessive e.g. unstable on short term Mechanical circulatory support (MCS)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
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. The study is of a descriptive nature. The primary outcome variable will be 30 day survival.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/08/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 29913 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 46270 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 322553 0
Self funded/Unfunded
Name [1] 322553 0
Country [1] 322553 0
Primary sponsor type
Government body
Name
Bayside Health
Address
Country
Australia
Secondary sponsor category [1] 325475 0
None
Name [1] 325475 0
Address [1] 325475 0
Country [1] 325475 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321031 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 321031 0
Ethics committee country [1] 321031 0
Australia
Date submitted for ethics approval [1] 321031 0
08/08/2024
Approval date [1] 321031 0
06/05/2025
Ethics approval number [1] 321031 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 152430 0
Dr Atsuo Doi
Address 152430 0
Department of Cardiothoracic Surgery, Alfred Hospital, Bayside Health, 55 Commercial Road, Melbourne VIC 3004
Country 152430 0
Australia
Phone 152430 0
+61 3 9076 3133
Fax 152430 0
Email 152430 0
[email protected]
Contact person for public queries
Name 152431 0
Dr Atsuo Doi
Address 152431 0
Department of Cardiothoracic Surgery, Alfred Hospital, Bayside Health, 55 Commercial Road, Melbourne VIC 3004
Country 152431 0
Australia
Phone 152431 0
+61 3 9076 313
Fax 152431 0
Email 152431 0
[email protected]
Contact person for scientific queries
Name 152432 0
Atsuo Doi
Address 152432 0
Department of Cardiothoracic Surgery, Alfred Hospital, Bayside Health, 55 Commercial Road, Melbourne VIC 3004
Country 152432 0
Australia
Phone 152432 0
+61 3 9076 3133
Fax 152432 0
Email 152432 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.