Transplant; Complication, Failure
Conditions
Keywords
renal transplantation, organ preservation, oxygen carrier
Brief summary
5 and 10 years follow-up of the oxyop study.
Detailed description
Oxyop (NCT02652520 PHRC) was a safety study evaluating the use of an oxygen carrier HEMO2life® as an additive in organ preservation solution in 60 transplanted kidneys. This was a national multicenter (6 centers) open-labeled safety study on HEMO2life® that included 58 recipients. The first patient was included on March 24th, 2016 and the study was completed on February 23th, 2018 (1 year of recruitment and 1 year of follow-up). Some efficacy secondary end points using a paired analysis was also analyzed (local kidney receiving HEMO2life® versus contralateral kidney transplanted elsewhere in France). Oxyop 5 and 10 years aims to analyse 5 and 10 years results.
Interventions
None listed
Sponsors
University Hospital, Brest
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* informed patients participating to the oxyop study * Patient having completed the OXYOP M12 follow-up visit * Patient agreeing to participate in the observational study
Exclusion criteria
* Opposition to the use his medical data * patient deceased or with graft lost before M48
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| eGFR | 10 years | estimated GFR (CKDEPI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| patient survival | 5 and 10 years | patient survival at last follow-up |
| graft survival | 5 and 10 years | graft survival at last follow-up |
| rejection rate | 5 and 10 years | biopsy proven rejection |
| infection rate | 5 and 10 years | all infection episodes |
| hospitalization | 5 and 10 years | number of hospitalization, hospital stay |
Countries
France
Contacts
Primary ContactYannick Le Meur, MD, PhD
Backup ContactChristelle RATAJCZAK
Outcome results
None listed