Back to Search Results

Comparison of the hemostatic efficacy of pathogen-reduced platelets vs untreated platelets in patients with thrombocytopenia and malignant hematologic diseases: a randomized clinical trial

University Grenoble Alpes, Centre National de Recherche Scientifique, Techniques de l'Ingenierie Medicale et de la Complexite-Institut Mathematiques Appliquees de Grenoble 38000, Grenoble, France. Service d'Hematologie, Centre Hospitalier Universitaire de Grenoble Alpes, Grenoble, France. Etablissement Francais du Sang, Grenoble, France. Centre d'Investigation Clinique 1406-Innovation Technologique, Institut national de la sante et de la recherche medicale, Grenoble, France. Service de Biostatistiques, Centre Hospitalier Universitaire de Grenoble Alpes, Grenoble, France. Service d'Hematologie, Hopital Lyon Sud, Hospices Civils de Lyon, Lyon, France. University Grenoble Alpes, Centre National de Recherche Scientifique, Techniques de l'Ingenierie Medicale et de la Complexite-Institut Mathematiques Appliquees de Grenoble 38000, Grenoble, France. Service d'Hematologie, Centre Hospitalier Universitaire de Grenoble Alpes, Grenoble, France. Service d'Hematologie, Centre Hospitalier Universitaire de Rennes, Rennes, France. Service d'Hematologie, Institut de Cancerologie Lucien Neuwirth, Saint-Priest-en-Jarez, France. Service d'Hematologie, Centre Hospitalier Universitaire de Dijon, Dijon, France. Service d'Hematologie, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France. Service d'Hematologie, Centre Hospitalier Universitaire de Lille, Lille, France. Service d'Hematologie, Centre Hospitalier Universitaire d'Angers, Angers, France. Service d'Hematologie, Centre Hospitalier Universitaire de Brest, Brest, France. Service d'Hematologie, Hopital Henri Mondor, Assistance Publique Hopitaux de Paris, Creteil, France. Service d'Hematologie, Institut Paoli Calmettes, Marseille, France. Service d'Hematologie, Hopital Saint-Antoine, Assistance Publique Hopitaux de Paris, Paris, France. Service d'Hematologie, Centre Hospitalier Universitaire de Besancon, Besancon, France. University Grenoble Alpes, Centre National de Recherche Scientifique, Techniques de l'Ingenierie Medicale et de la Complexite-Institut Mathematiques Appliquees de Grenoble 38000, Grenoble, France. Cellule Publication, Centre Hospitalier Universitaire de Grenoble Alpes, Grenoble, France. Etablissement Francais du Sang, La Plaine Saint-Denis, France. Etablissement Francais du Sang, La Plaine Saint-Denis, France. Etablissement Francais du Sang, La Plaine Saint-Denis, France. Etablissement Francais du Sang, Rennes, France. Etablissement Francais du Sang, La Plaine Saint-Denis, France. Unite mixte de recherche 1098, Institut national de la sante et de la recherche medicale, Universite de Franche-Comte, Etablissement Francais du Sang, Besancon, France. University Grenoble Alpes, Centre National de Recherche Scientifique, Techniques de l'Ingenierie Medicale et de la Complexite-Institut Mathematiques Appliquees de Grenoble 38000, Grenoble, France. Centre d'Investigation Clinique 1406-Innovation Technologique, Institut national de la sante et de la recherche medicale, Grenoble, France. Service de Biostatistiques, Centre Hospitalier Universitaire de Grenoble Alpes, Grenoble, France.

Jama Oncology. 2018;4((4):):468-475
Full text from:

Other resources

Abstract
Importance: Pathogen reduction of platelet concentrates may reduce transfusion-transmitted infections but is associated with qualitative impairment, which could have clinical significance with regard to platelet hemostatic capacity. Objective: To compare the effectiveness of platelets in additive solution treated with amotosalen-UV-A vs untreated platelets in plasma or in additive solution in patients with thrombocytopenia and hematologic malignancies. Design, Setting, and Participants: The Evaluation of the Efficacy of Platelets Treated With Pathogen Reduction Process (EFFIPAP) study was a randomized, noninferiority, 3-arm clinical trial performed from May 16, 2013, through January 21, 2016, at 13 French tertiary university hospitals. Clinical signs of bleeding were assessed daily until the end of aplasia, transfer to another department, need for a specific platelet product, or 30 days after enrollment. Consecutive adult patients with bone marrow aplasia, expected hospital stay of more than 10 days, and expected need of platelet transfusions were included. Interventions: At least 1 transfusion of platelets in additive solution with amotosalen-UV-A treatment, in plasma, or in additive solution. Main Outcomes and Measures: The proportion of patients with grade 2 or higher bleeding as defined by World Health Organization criteria. Results: Among 790 evaluable patients (mean [SD] age, 55 [13.4] years; 458 men [58.0%]), the primary end point was observed in 126 receiving pathogen-reduced platelets in additive solution (47.9%; 95% CI, 41.9%-54.0%), 114 receiving platelets in plasma (43.5%; 95% CI, 37.5%-49.5%), and 120 receiving platelets in additive solution (45.3%; 95% CI, 39.3%-51.3%). With a per-protocol population with a prespecified margin of 12.5%, noninferiority was not achieved when pathogen-reduced platelets in additive solution were compared with platelets in plasma (4.4%; 95% CI, -4.1% to 12.9%) but was achieved when the pathogen-reduced platelets were compared with platelets in additive solution (2.6%; 95% CI, -5.9% to 11.1%). The proportion of patients with grade 3 or 4 bleeding was not different among treatment arms. Conclusions and Relevance: Although the hemostatic efficacy of pathogen-reduced platelets in thrombopenic patients with hematologic malignancies was noninferior to platelets in additive solution, such noninferiority was not achieved when comparing pathogen-reduced platelets with platelets in plasma. Trial Registration: clinicaltrials.gov Identifier: NCT01789762.
Study details
Language : English
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine