6533b82cfe1ef96bd128f7a3

RESEARCH PRODUCT

Buffy coat-derived platelets cryopreserved using a new method: Results from a pivotal clinical trial on thrombocytopenic patients with acute leukaemia

Nadia CaccamoRosalia AgliastroPiera Stefania ArfòGiovanni De FrancisciMariasanta NapolitanoLucio LococoFrancesco DieliSimona RasoSergio SiragusaAlberto DolceAmalia ReinaSalvatrice Mancuso

subject

Blood PlateletsMalemedicine.medical_specialtymedicine.medical_treatmentPlatelet TransfusionBuffy coat030204 cardiovascular system & hematologyAcute leukaemiaCryopreservation03 medical and health sciences0302 clinical medicineInternal medicinemedicineHumansPlateletAdverse effectAgedAged 80 and overCryopreservationChemotherapybusiness.industryTransfusionThrombinSevere thrombocytopeniaThrombosisHematologyCryopreserved plateletThrombocytopeniaSevere thrombocytopeniaClinical trialLeukemia Myeloid AcuteBlood PreservationConcomitantBlood Buffy CoatFemaleSafetybusiness030215 immunology

description

Abstract The administration of cryopreserved platelets (PLTs) may overcome the limits of platelet shortage and availability, especially during some seasons or in specific contexts like rural areas. After in vitro validation studies, ad hoc prepared buffy coat-derived pooled platelet concentrates (BC-PLTs), treated with dimethyl sulphoxide (DMSO) and cryopreserved (CRY BC-PLTs) at -80 °C with a modified Valeri method, were transfused in patients with severe thrombocytopenia secondary to chemotherapy for acute leukaemia (AL). Five inpatients were enrolled in the pivotal clinical trial NCT02032134: 4 males and 1 female with a mean age of 71 years (range: 65–80). Four patients were diagnosed with acute myeloid leukaemia and 1 had acute lymphoblastic leukaemia.Transfusion of one Unit of CRY BC-PLTs resulted effective in active bleeding control in two patients without any adverse reaction or concomitant antihaemorrhagic therapies. CRY BC-PLTs met the currently accepted criteria for cryopreserved PLTs, their transfusion in patients with AL was safe. (Clinical trial: NCT02032134).

yearjournalcountryeditionlanguage
2019-05-15Transfusion and Apheresis Science
https://doi.org/10.1016/j.transci.2019.10.008