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An epitope-based approach of HLA-matched platelets for transfusion: a noninferiority crossover randomized trial.
Marsh, Judith C; Stanworth, Simon J; Pankhurst, Laura A; Kallon, Delordson; Gilbertson, Adeline Z; Pigden, Collette; Deary, Alison J; Mora, Ana S; Brown, Joanne; Laing, Emma S; Choo, Louise L; Hodge, Renate; Llewelyn, Charlotte A; Harding, Kay; Sage, Deborah; Mijovic, Aleksandar; Mufti, Ghulam J; Navarrete, Cristina V; Brown, Colin J.
Afiliación
  • Marsh JC; Department of Haematological Medicine, King's College Hospital, London, United Kingdom.
  • Stanworth SJ; Department of Haematology, School of Cancer and Pharmaceutical Sciences, Faculty of Life Sciences and Medicine, King's College London, London, United Kingdom.
  • Pankhurst LA; Transfusion Medicine, NHS Blood and Transplant (NHSBT), Oxford, United Kingdom.
  • Kallon D; Department of Haematology, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom.
  • Gilbertson AZ; Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom.
  • Pigden C; NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom.
  • Deary AJ; NHSBT Clinical Trials Unit, Cambridge, United Kingdom.
  • Mora AS; NHSBT Clinical Trials Unit, Bristol, United Kingdom.
  • Brown J; Haematology, Barts and The London Hospital, London, United Kingdom.
  • Laing ES; H&I Laboratory, NHSBT, Colindale, United Kingdom.
  • Choo LL; Department of Haematological Medicine, King's College Hospital, London, United Kingdom.
  • Hodge R; Department of Haematology, School of Cancer and Pharmaceutical Sciences, Faculty of Life Sciences and Medicine, King's College London, London, United Kingdom.
  • Llewelyn CA; NHSBT Clinical Trials Unit, Cambridge, United Kingdom.
  • Harding K; NHSBT Clinical Trials Unit, Bristol, United Kingdom.
  • Sage D; NHSBT Clinical Trials Unit, Cambridge, United Kingdom.
  • Mijovic A; NHSBT Clinical Trials Unit, Bristol, United Kingdom.
  • Mufti GJ; NHSBT Clinical Trials Unit, Cambridge, United Kingdom.
  • Navarrete CV; NHSBT Clinical Trials Unit, Cambridge, United Kingdom.
  • Brown CJ; NHSBT Clinical Trials Unit, Bristol, United Kingdom.
Blood ; 137(3): 310-322, 2021 01 21.
Article en En | MEDLINE | ID: mdl-33475737
ABSTRACT
Platelet transfusion refractoriness results in adverse outcomes and increased health care costs. Managing refractoriness resulting from HLA alloimmunization necessitates the use of HLA antigen-matched platelets but requires a large platelet donor pool and does not guarantee full matching. We report the first randomized, double-blind, noninferiority, crossover trial comparing HLA epitope-matched (HEM) platelets with HLA standard antigen-matched (HSM) platelet transfusions. Alloimmunized, platelet-refractory, thrombocytopenic patients with aplastic anemia, myelodysplastic syndrome, or acute myeloid leukemia were eligible. HEM platelets were selected using HLAMatchMaker epitope (specifically eplet) matching. Patients received up to 8 prophylactic HEM and HSM transfusions provided in random order. The primary outcome was 1-hour posttransfusion platelet count increment (PCI). Forty-nine patients were randomized at 14 UK hospitals. For intention to treat, numbers of evaluable transfusions were 107 and 112 for HEM and HSM methods, respectively. Unadjusted mean PCIs for HEM and HSM methods were 23.9 (standard deviation [SD], 15) and 23.5 (SD, 14.1), respectively (adjusted mean difference, -0.1; 95% confidence interval [CI], -2.9 to 2.8). Because the lower limit of the 95% CI was not greater than the predefined noninferiority limit, the HEM approach was declared noninferior to the HSM approach. There were no differences in secondary outcomes of platelet counts, transfusion requirements, and bleeding events. Adequate 1-hour PCI was more frequently observed, with a mean number of 3.2 epitope mismatches, compared with 5.5 epitope mismatches for inadequate 1-hour increments. For every additional epitope mismatch, the likelihood of an adequate PCI decreased by 15%. Epitope-matched platelets should be considered to support HLA alloimmunized patients. This trial was registered at www.isrctn.com as #ISRCTN23996532.
Asunto(s)

Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Plaquetas / Prueba de Histocompatibilidad / Transfusión de Plaquetas / Antígenos HLA / Epítopos Tipo de estudio: Clinical_trials Límite: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Blood Año: 2021 Tipo del documento: Article País de afiliación: Reino Unido

Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Plaquetas / Prueba de Histocompatibilidad / Transfusión de Plaquetas / Antígenos HLA / Epítopos Tipo de estudio: Clinical_trials Límite: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Blood Año: 2021 Tipo del documento: Article País de afiliación: Reino Unido