None listed
Conditions
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.
Interventions
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/Prese
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).
Sponsors
Alfred Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
2 Years to 80 No limit
Healthy volunteers
No
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
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
Outcome results
None listed