End Stage Renal Diseases
Conditions
Keywords
Kidney transplantation, Organ preservation
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREHEMO2Life® use in organ preservation solution
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.
Sponsors
University Hospital, Brest
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HEMO2Life® adverse effects | During 3 months | All incidents and events of interest occurring during the use of HEMO2Life® will be collected |
| Graft safety | During 3 months | 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. |
| Recipient safety (any adverse event) | During 3 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the graft survival criteria with a control population | Baseline to 12 months | 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. |
| Histological evaluation of the graft on biopsies | pre-implantation to 3-month 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. |
| Analysis of markers involved in kydney regeneration and neovascularization and markers of cellular stress. | Baseline to 12 months | Analysis of blood and urine biomarkers at each visit. |
Countries
France
Outcome results
None listed