Kidney Preservation and Transportation
Conditions
Keywords
VIVIAN
Brief summary
TB1-K Device is an organ preservation and transportation system, using ultrasound technology with a cooling system to preserve the organ in optimal conditions during transport to the transplant recipient. This is a prospective, single-arm, multi-center study comparing to a historical control for cold storage. The study is conducted in accordance with the Standard ISO 14155 (Clinical investigation of medical devices for human subjects - Good clinical practice), and other legal requirements. The study objective is to assess the safety and performance of the TB1-K device in donor kidneys intended for transplantation.
Interventions
DEVICETB1-K
Use of TB1-K for preservation and transport of donated kidneys
Sponsors
Transplant Biomedicals, S.L.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Donor Inclusion Criteria: 1. Donor kidney suitable for preservation 2. Only one kidney per donor will be included 3. Cold ischemia time (CIT) ≤ 24 hours 4. Donor age over 18 years old 5. Donor meets one of the following: 1. Donor after brain death (DBD), standard and extended criteria 2. Donor after circulatory death (DCD), cardiac arrest Maastricht classification III (awaiting cardiac arrest, controlled) 6. Signed written informed consent Donor
Exclusion criteria
1. Kidney, which investigator is unwilling to use, or presence of moderate or severe traumatic kidney injury, or anatomical kidney vascular abnormalities, which would preclude the organ from being acceptable by the transplant surgeon 2. Donor after circulatory death (DCD), Maastricht classification I, II, IV, V (See Definitions, section 14) 3. Living donors 4. Previous usage of a perfusion machine (PM) 5. Kidneys not considered suitable for preservations 6. Positive serology (HIV, Hepatitis B surface antigen & C) Recipient Inclusion Criteria: 1. Registered primary kidney transplant candidate, male or female 2. Age ≥ 18 years old 3. Signed written informed consent Recipient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of DGF | 1 week after transplant | Rate of delayed graft function (DGF), defined as need for dialysis in the first week after transplant, once hyperacute rejection, vascular and urinary tract complications are ruled out. |
Countries
Spain
Outcome results
None listed