NCT02652520

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• End Stage Renal Diseases

Interventions

Type	Name	Description
PROCEDURE	HEMO2Life® 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.

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-02-23
• Completion: 2018-02-23
• First posted: 2016-01-12
• Last updated: 2018-03-19

Locations

6 sites across 1 country: France