Evaluation of a Marine OXYgen Carrier for Organ Preservation
NCT ID: NCT04181710
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
490 participants
INTERVENTIONAL
2020-07-04
2023-09-11
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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HEMO2life
HEMO2life® will be used for ex vivo graft preservation at the dose of 1g per liter of preservation solution.
Kidney transplant
Organ preserved in preservation solution
Control
Organ preserved in preservation solution routinely used according to the local practice
Kidney transplant
Organ preserved in preservation solution
Interventions
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Kidney transplant
Organ preserved in preservation solution
Eligibility Criteria
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Inclusion Criteria
* Any pair of kidneys retrieved in an adult donor in one of first line participating centers.
* Any pair of kidneys from a deceased donor after brain or cardiac death
* For Patient:
* Male or female renal allograft recipients at least 18 years old
* Patient who signed an inform consent form
* Patient receiving one graft from an included pair of kidneys
Exclusion Criteria
* Graft from a living donor
* Graft dedicated to a multi-organ transplantation or dual kidney transplantation,
18 Years
ALL
No
Sponsors
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University Hospital, Brest
OTHER
Responsible Party
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Principal Investigators
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Yannick LE MEUR
Role: PRINCIPAL_INVESTIGATOR
Principal Investigator and Nephrology coordinator
Benoit BARROU
Role: PRINCIPAL_INVESTIGATOR
Urology coordinator
Locations
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Amiens
Amiens, , France
Angers
Angers, , France
Besançon
Besançon, , France
Bordeaux
Bordeaux, , France
CHRU de Brest
Brest, , France
Caen
Caen, , France
Clermont-Ferrand
Clermont-Ferrand, , France
Dijon
Dijon, , France
Grenoble
Grenoble, , France
Lille
Lille, , France
Limoges
Limoges, , France
Lyon
Lyon, , France
Marseille
Marseille, , France
Montpellier
Montpellier, , France
Nancy
Nancy, , France
Nantes
Nantes, , France
Nice
Nice, , France
APHP Bicêtre
Paris, , France
APHP Henri Mondor
Paris, , France
APHP Necker
Paris, , France
APHP Saint-Louis
Paris, , France
Association Hopital Foch
Paris, , France
Paris La Salpétrière
Paris, , France
Poitiers
Poitiers, , France
Reims
Reims, , France
Rennes
Rennes, , France
Rouen
Rouen, , France
La Réunion
Saint-Denis, , France
Saint-Etienne
Saint-Etienne, , France
Strasbourg
Strasbourg, , France
Toulouse
Toulouse, , France
Tours
Tours, , France
Countries
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References
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Tingle SJ, Thompson ER, Figueiredo RS, Moir JA, Goodfellow M, Talbot D, Wilson CH. Normothermic and hypothermic machine perfusion preservation versus static cold storage for deceased donor kidney transplantation. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD011671. doi: 10.1002/14651858.CD011671.pub3.
Le Meur Y, Nowak E, Barrou B, Thierry A, Badet L, Buchler M, Rerolle JP, Golbin L, Duveau A, Dantal J, Merville P, Kamar N, Demini L, Zal F. Evaluation of the efficacy of HEMO2life(R), a marine OXYgen carrier for Organ Preservation (OxyOp2) in renal transplantation: study protocol for a multicenter randomized trial. Trials. 2023 May 1;24(1):302. doi: 10.1186/s13063-023-07302-3.
Other Identifiers
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OXYOP 2 (29BRC19.0048)
Identifier Type: -
Identifier Source: org_study_id