Non-ischaemic Heart Preservation Versus Standard Cold Storage in Human Heart Transplantation (NCT04066127) | Clinical Trial Compass
By InvitationNot Applicable
Non-ischaemic Heart Preservation Versus Standard Cold Storage in Human Heart Transplantation
Sweden66 participantsStarted 2020-07-01
Plain-language summary
The overall aim of this study is to compare a new state-of-the-art ex-vivo organ preservation method with standard ischemic cold static storage of donor hearts in adult cardiac transplantation.
Standard heart preservation before transplantation consists of cold ischemic storage of the heart. Clinical studies have shown that the morbidity and mortality risk increases with the extension of the allograft ischemic time over four hours. For each additional hour the mortality risk increase with 25% the first year. This time constraint is costly and results in severe logistical problems, leading to loss of transplantable organs. The preliminary results from our safety study, where six patients transplanted with the new state-of-the-art ex-vivo organ preservation method, have shown promising results.
The study is a multicenter, prospective, open, blinded endpoint, randomized, controlled clinical trial. The primary end-point is survival free of acute cellular rejection (ACR) and retransplantation within 1-year post-transplant. ACR will be assessed blinded. The secondary end-points are ischemia/reperfusion injury, early graft dysfunction, and QoL.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria recipient:
* Age ≥18 years
* Signed informed consent form
* Listed for heart transplantation
Exclusion Criteria recipient:
* Previous solid organ transplantation
* Grown-up congenital heart disease (GUCH)
* Kidney failure eGFR\<40, calculated by CDK-EPI Creatinine, or ultrafiltration or dialysis or rapidly deteriorating kidney function due to a diagnosed renal disease
* Coagulopathy due to known hepatic disease or heparin induced thrombocytopenia
* Ongoing septicemia defined as positive blood culture (including with a durable VAD)
* Incompatible blood group
* Not able to understand the information provided during the informed consent procedure
* Patients under pre-transplant desensitization protocol
* Short term mechanical support pre-transplant (ECMO)
* Patient diagnosed with Systemic Lupus Erythematous, sarcoidosis or amyloidosis
* Combined organ transplantation candidates
* Patient already consented for another transplant related intervention study
Inclusion criteria donor:
* Age ≤70 years
* Accepted as heart donor by the transplant team (research consent from the donor if required in country)
Exclusion criteria donor:
* Previous sternotomy
* DCD hearts
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Survival free of acute cellular rejection and re-transplantation