Status:
ENROLLING_BY_INVITATION
Non-ischaemic Heart Preservation Versus Standard Cold Storage in Human Heart Transplantation
Lead Sponsor:
Region Skane
Collaborating Sponsors:
Lund University
Skane University Hospital
Conditions:
Transplant; Failure, Heart
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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. Stand...
Detailed Description
SURVEY OF THE FIELD Ischemia and reperfusion (I/R) - elicited tissue injury contributes to morbidity and mortality. In organ transplantation, it is a major challenge. The imbalance in metabolic supply...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04066127
Start Date
July 1 2020
End Date
December 31 2026
Last Update
May 8 2025
Active Locations (1)
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1
Skane University Hospital
Lund, Skåne County, Sweden, 22185