Prevention of veno-occlusive disease/sinusoidal obstruction syndrome: a never-ending story and no easy answer
Selim Corbacioglu, Stephan A. Grupp, Paul G. Richardson, Rafael F. Duarte, Antonio Pagliuca, Tapani Ruutu, Kris M. Mahadeo, Enric Carreras
Abstract
The Harmony Trial (NCT02851407), a prospective randomized trial conducted among adults and children, reported that defibrotide was not effective for the prevention of veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) [ 1 ]. Importantly no safety concerns were raised [ 2 ], but consecutively, in May 2022, the European Medicines Agency (EMA) recommended not to use defibrotide for prophylaxis of VOD/SOS ( https://www.ema.europa.eu/en/medicines/dhpc/defitelio-defibrotide-do-not-use-prophylaxis-veno-occlusive-disease-vod-after-post-hematopoietic ).
Topics & Concepts
MedicineHepatic veno-occlusive diseaseOcclusiveDiseaseSurgeryOcclusive arterial diseaseInternal medicineVascular diseaseArterial diseaseHematopoietic stem cell transplantationHematological disorders and diagnosticsVenous Thromboembolism Diagnosis and ManagementHematopoietic Stem Cell Transplantation