Evaluation of a Marine OXYgen Carrier: HEMO2Life® for hypOthermic Kidney Graft Preservation, Before Transplantation (OXYOP)

University Hospital, Brest60 enrolled

Overview

Kidney transplantation is the treatment of choice for end stage renal diseases, increasing life expectancy and quality of life. Improvement in organ preservation is a critical issue in this context. This is a safety study evaluating the use of an oxygen carrier HEMO2Life® as an additive in organ preservation solution in kidney transplantation.

Security of the use of HEMO2Life® will be analyzed by collecting all events within the first 3 months in terms of : 1. HEMO2Life® adverse effects 2. graft safety 3. recipient safety (any adverse event) Accountability search will be achieved for each of these events.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

End Stage Renal Diseases

Interventions

HEMO2Life® use in organ preservation solutionPROCEDURE

The surgeon decides whether the local transplant kidney may be part of the study and whether it should be stored in static cold storage or machine perfusion. The transplant kidney will be perfused in situ before procurement with the Belzer UW® cold storage solution furnish by the BridgetoLife company. HEMO2Life® will then be added to preservation solution.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: For Kidney : The first ten local kidneys in each participating centers that do not meet the exclusion criteria. * Graft retrieved in an adult donor * Graft from a deceased donor after brain death (DBD) * Graft locally transplanted in one of the 6 kidney transplant centers participating in the study * Graft stored in preservation solution containing HEMO2Life® For Patient : Patient who signed an inform consent form In case of patient unable to signed an inform consent form for patient under judicial protection (supervision, guardianship) the inform consent form will be obtain from the patient himself and from the supervisor/guardianshiper/parents, they will signed together the patient inform consent form. The probability of the inclusion of a patient unable to signed an inform consent form is low but we can't know the receiver before conditioning the graft. Patient \> 18 years old Exclusion Criteria: * Graft from a living donor * Graft from a donor after cardiovascular death (DCD) * Graft dedicated to a multi-organ transplantation

Locations (6)

CHRU Brest

Brest, France

CHU Limoges

Limoges, France

Hôpital Edouard Herriot

Lyon, France

Hôpital la Pitié Salpetrière

Paris, France

CHU Poitiers

Outcomes

Primary Outcomes

HEMO2Life® adverse effects

All incidents and events of interest occurring during the use of HEMO2Life® will be collected

Time frame: During 3 months

Graft safety

Collecting any complication with particular attention to mascroscopic aspect, contamination of the conservation solution, surgical difficulties and thrombosis, primary non function, delayed graft function, slow recovery of graft function, acute rejection, or any other graft complications.

Time frame: During 3 months

Recipient safety (any adverse event)

All adverse events, even unrelated to HEMO2Life®, occuring during the first 3 months after transplantation will be collected. Vital signs and laboratory evaluations will be collected at D0, D1, D3, D7, D14, M1, M2 and M3 to evaluate the recipient safety

Time frame: During 3 months

Secondary Outcomes

Comparison of the graft survival criteria with a control population

Results will be compared with patients from a case control group of grafts transplanted at the same time in the 4 transplant centers from the Spiesser group (Tours, Poitiers, Brest, Limoges). Groups will be formed after matching on sex, age and cold ischemia time thanks to the Astre database regrouping the data of all the transplant teams from the Spiesser group.

Time frame: Baseline to 12 months

Histological evaluation of the graft on biopsies

All biopsies are interpreted locally and classified according to the Banff classification. Interstitial fibrosis quantification using automated quantitative image analysis of biopsies will also be performed from each biopsy.

Time frame: pre-implantation to 3-month biopsies

Analysis of markers involved in kydney regeneration and neovascularization and markers of cellular stress.

Data from ClinicalTrials.gov

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