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

Nadia Rosalia Caccamo, Simona Raso, Francesco Dieli, Sergio Siragusa, Salvatrice Mancuso, Mariasanta Napolitano, Rosalia Agliastro, Giovanni De Francisci, Amalia Reina, Lucio Lococo, Alberto Dolce, Alberto Dolce, Piera Stefania Arfo', Rosalia Agliastro

Risultato della ricerca: Article

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)
Lingua originaleEnglish
pagine (da-a)102666-
Numero di pagine4
RivistaTransfusion and Apheresis Science
Stato di pubblicazionePublished - 2019

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Leukemia
Blood Platelets
Clinical Trials
Platelet Transfusion
Validation Studies
Hemostatics
Dimethyl Sulfoxide
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Acute Myeloid Leukemia
Thrombocytopenia
Inpatients
Hemorrhage
Drug Therapy
Therapeutics

All Science Journal Classification (ASJC) codes

  • Hematology

Cita questo

Buffy coat-derived platelets cryopreserved using a new method: Results from a pivotal clinical trial on thrombocytopenic patients with acute leukaemia. / Caccamo, Nadia Rosalia; Raso, Simona; Dieli, Francesco; Siragusa, Sergio; Mancuso, Salvatrice; Napolitano, Mariasanta; Agliastro, Rosalia; De Francisci, Giovanni; Reina, Amalia; Lococo, Lucio; Dolce, Alberto; Dolce, Alberto; Arfo', Piera Stefania; Agliastro, Rosalia.

In: Transfusion and Apheresis Science, 2019, pag. 102666-.

Risultato della ricerca: Article

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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)",
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AU - Caccamo, Nadia Rosalia

AU - Raso, Simona

AU - Dieli, Francesco

AU - Siragusa, Sergio

AU - Mancuso, Salvatrice

AU - Napolitano, Mariasanta

AU - Agliastro, Rosalia

AU - De Francisci, Giovanni

AU - Reina, Amalia

AU - Lococo, Lucio

AU - Dolce, Alberto

AU - Dolce, Alberto

AU - Arfo', Piera Stefania

AU - Agliastro, Rosalia

PY - 2019

Y1 - 2019

N2 - 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)

AB - 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)

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JO - Transfusion and Apheresis Science

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SN - 1473-0502

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