NCT04181710

Evaluation of a Marine OXYgen Carrier for Organ Preservation

Evaluation of a Marine OXYgen Carrier for Organ Preservation : a Multicenter Randomized Study Evaluating the Efficacy of HEMO2life® Versus Standard of Care in Renal Transplantation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 490 (actual)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Preventing ischemia/reperfusion injuries (IRIs) is a major issue in kidney transplantation, particularly for transplant recipients receiving a kidney from extended criteria donors (ECD). The main consequence of IRIs is delayed graft function (DGF). The medical device HEMO2life®, an oxygen carrier developed by the Hemarina French Company, is a natural extracellular hemoglobin (Hb) isolated from the marine lugworm Arenicola marina. This biopolymer of high molecular weight (\~3,600 kDa) has a large oxygen binding capacity, carrying up to 156 oxygen molecules when saturated (4 for human Hb). It releases oxygen according to a simple gradient and exhibits an intrinsic superoxide dismutase-like activity preventing both the occurrence of potentially harmful heme-protein-associated free radical species and the release of Hb degradation products. Recently a safety study in 60 renal grafts using HEMO2life® as additive to organ preservation solution (Oxyop study, NCT02652520) was completed, that confirmed that the use of HEMO2life® is safe for patients and grafts. In the Oxyop study, even if the protocol was not designed to show a benefit of the use of HEMO2life®, significantly less delayed graft function (DGF) and a shorter renal function recovery was observed. The present research focuses on the efficacy of HEMO2life®, which is an oxygen carrier added in preservation solution in kidney transplantation.

Conditions

• End Stage Renal Diseases

Interventions

Type	Name	Description
PROCEDURE	Kidney transplant	Organ preserved in preservation solution

Timeline

• Start date: 2020-07-04
• Primary completion: 2022-07-12
• Completion: 2023-09-11
• First posted: 2019-11-29
• Last updated: 2023-11-29

Locations

32 sites across 1 country: France