Trials / Unknown
UnknownNCT05050513
Evaluation of HEMO2Life® for Kidney Graft Preservation (OXYOP): 4 Years Follow-up
Evaluation of a Marine OXYgen Carrier (HEMO2Life®) for hypOthermic Kidney Graft Preservation Before Transplantation (OXYOP): 4 Years Follow-up
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 116 (estimated)
- Sponsor
- University Hospital, Brest · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
4 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). 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.
Conditions
Timeline
- Start date
- 2021-05-01
- Primary completion
- 2021-10-01
- Completion
- 2021-10-01
- First posted
- 2021-09-20
- Last updated
- 2021-09-20
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT05050513. Inclusion in this directory is not an endorsement.