4 years follow-up of the oxyop study.
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). We also analyzed some efficacy secondary end points using a paired analysis (local kidney receiving HEMO2life® versus contralateral kidney transplanted elsewhere in France). Oxyop4 aims to analyse 4 years results.
Study Type
OBSERVATIONAL
Enrollment
116
CHU de Brest
Brest, France
RECRUITINGeGFR
estimated GFR (CKDEPI)
Time frame: 4 years
patient survival
patient survival at last follow-up
Time frame: 4 years
graft survival
graft survival at last follow-up
Time frame: 4 years
rejection rate
biopsy proven rejection
Time frame: 4 years
infection rate
all infection episodes
Time frame: 4 years
hospitalization
number of hospitalization, hospital stay
Time frame: 4 years
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