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Combined Platelet and Red Blood Cell Recovery during On-pump Cardiac Surgery Using same™ by i-SEP Autotransfusion Device: A First-in-human Noncomparative Study (i-TRANSEP Study).

dc.rights.licenseopenen_US
dc.contributor.authorMANSOUR, Alexandre
hal.structure.identifierBiologie des maladies cardiovasculaires = Biology of Cardiovascular Diseases
dc.contributor.authorBEURTON, Antoine
dc.contributor.authorGODIER, Anne
dc.contributor.authorROZEC, Bertrand
dc.contributor.authorZLOTNIK, Diane
dc.contributor.authorNEDELEC, Fabienne
dc.contributor.authorGAUSSEM, Pascale
hal.structure.identifierBiologie des maladies cardiovasculaires = Biology of Cardiovascular Diseases
dc.contributor.authorFIORE, Mathieu
dc.contributor.authorBOISSIER, Elodie
dc.contributor.authorNESSELER, Nicolas
hal.structure.identifierBiologie des maladies cardiovasculaires = Biology of Cardiovascular Diseases
dc.contributor.authorOUATTARA, Alexandre
dc.date.accessioned2023-10-09T14:18:10Z
dc.date.available2023-10-09T14:18:10Z
dc.date.issued2023-09-01
dc.identifier.issn1528-1175en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/184366
dc.description.abstractEnCentrifugation-based autotransfusion devices only salvage red blood cells while platelets are removed. The same™ device (Smart Autotransfusion for ME; i-SEP, France) is an innovative filtration-based autotransfusion device able to salvage both red blood cells and platelets. The authors tested the hypothesis that this new device could allow a red blood cell recovery exceeding 80% with a posttreatment hematocrit exceeding 40%, and would remove more than 90% of heparin and 75% of free hemoglobin. Adults undergoing on-pump elective cardiac surgery were included in a noncomparative multicenter trial. The device was used intraoperatively to treat shed and residual cardiopulmonary bypass blood. The primary outcome was a composite of cell recovery performance, assessed in the device by red blood cell recovery and posttreatment hematocrit, and of biologic safety assessed in the device by the washout of heparin and free hemoglobin expressed as removal ratios. Secondary outcomes included platelet recovery and function and adverse events (clinical and device-related adverse events) up to 30 days after surgery. The study included 50 patients, of whom 18 (35%) underwent isolated coronary artery bypass graft, 26 (52%) valve surgery, and 6 (12%) aortic root surgery. The median red blood cell recovery per cycle was 86.1% (25th percentile to 75th percentile interquartile range, 80.8 to 91.6) with posttreatment hematocrit of 41.8% (39.7 to 44.2). Removal ratios for heparin and free hemoglobin were 98.9% (98.2 to 99.7) and 94.6% (92.7 to 96.6), respectively. No adverse device effect was reported. Median platelet recovery was 52.4% (44.2 to 60.1), with a posttreatment concentration of 116 (93 to 146) · 109/l. Platelet activation state and function, evaluated by flow cytometry, were found to be unaltered by the device. In this first-in-human study, the same™ device was able to simultaneously recover and wash both platelets and red blood cells. Compared with preclinical evaluations, the device achieved a higher platelet recovery of 52% with minimal platelet activation while maintaining platelet ability to be activated in vitro.
dc.language.isoENen_US
dc.subjectArticle clinique
dc.subject.enAdult
dc.subject.enHumans
dc.subject.enBlood Transfusion
dc.subject.enAutologous
dc.subject.enBlood Platelets
dc.subject.enErythrocytes
dc.subject.enCardiac Surgical Procedures
dc.subject.enHemoglobins
dc.subject.enHeparin
dc.title.enCombined Platelet and Red Blood Cell Recovery during On-pump Cardiac Surgery Using same™ by i-SEP Autotransfusion Device: A First-in-human Noncomparative Study (i-TRANSEP Study).
dc.title.alternativeAnesthesiologyen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1097/ALN.0000000000004642en_US
dc.subject.halSciences du Vivant [q-bio]/Médecine humaine et pathologieen_US
dc.identifier.pubmed37294939en_US
bordeaux.journalAnesthesiologyen_US
bordeaux.page287-297en_US
bordeaux.volume139en_US
bordeaux.hal.laboratoriesBiologie des maladies cardiovasculaires (BMC) - UMR 1034en_US
bordeaux.issue3en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
bordeaux.import.sourcepubmed
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exportfalse
workflow.import.sourcepubmed
dc.rights.ccPas de Licence CCen_US
bordeaux.COinSctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=Anesthesiology&rft.date=2023-09-01&rft.volume=139&rft.issue=3&rft.spage=287-297&rft.epage=287-297&rft.eissn=1528-1175&rft.issn=1528-1175&rft.au=MANSOUR,%20Alexandre&BEURTON,%20Antoine&GODIER,%20Anne&ROZEC,%20Bertrand&ZLOTNIK,%20Diane&rft.genre=article


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