| Title {1} | Evaluation of the efficacy of HEMO2life®, a marine OXYgen carrier for Organ Preservation (OxyOp2) in renal transplantation: Study protocol for a multicenter randomized trial |
|---|---|
| Trial registration {2a and 2b} | ClinicalTrials.gov, ID: NCT04181710. registered on November 29, 2019 |
| Protocol version {3} | February 22 nd, 2022, Version 3 |
| Funding {4} | This study was supported by a grant from the French Ministry of Health (PHRCN 2018), and was cosponsored by HEMARINA |
| Author details {5a} | 1Department of Nephrology, Hôpital de la Cavale Blanche, CHRU de Brest, Brest, France. 2Centre d'Investigation Clinique INSERM CIC 1412, Hôpital de la Cavale Blanche, CHRU de Brest, Brest, France, 3Public Agency for Clinical Research and Innovation (DRCI), Brest University Hospital, Brest, France, 4Department of Urology, Nephrology and Transplantation, Assistance Publique-Hôpitaux de Paris AP-HP, Hôpitaux Universitaire de la Pitié Salpétrière-Charles Foix, Paris, France. 5Department of Nephrology, CHU la Milétrie, Poitiers, France. 6Department of Urology, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France. 7Department of Urology, Hôpital Bretonneau, CHRU de Tours, Tours, France. 8Department of Nephrology, CHU Dupuytren, Limoges, France. 9Department of Nephrology, CHU de Rennes, France. 10Department of Nephrology and Urology, CHU d’Angers, Angers, France. 11Department of Nephrology and Urology, CHU de Nantes, Nantes, France. 12Department of Nephrology and Urology, Hôpital Pellegrin, Bordeaux, France. 13Department of Nephrology and Urology, Hôpital Rangueil, CHU de Toulouse, Toulouse, France. 14HEMARINA, Aéropôle Centre, Morlaix, France |
| Name and contact information for the trial sponsor {5b} |
Brest University Hospital Direction de la Recherche et de l’Innovation Avenue Foch 29,609 BREST CEDEX—FRANCE Phone: + 33.2.98.22.39.79 Fax: + 33.2.98.22.31.83 |
| Role of sponsor {5c} | Monitoring of the collected data and screening forms in each participating centre will be carried out by the sponsor. The funding source has no influence on trial design, trial conduct, data handling, data analysis or writing of the manuscript |
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