Evaluate the Efficacy and Safety of Red Blood Cells (RBCs) Derived from Mirasol-Treated Whole Blood Compared with Conventional RBCs in Patients Requiring Chronic Transfusion Support (PRAISE Trial)
Primary Investigator: Sujit Sheth
This prospective, multi-center, randomized, crossover trial will evaluate the clinical effectiveness of RBCs derived from Mirasol-treated whole blood versus conventional whole-blood-derived RBCs in transfusion-dependent thalassemia patients. Throughout the clinical study, whole-blood-derived RBC transfusion volume and frequency will be determined by each subject's physician. Eligible subjects who have signed an informed or parental consent form, and assent form where applicable, will be enrolled and randomized 1:1 to a treatment sequence via an electronic system using a permuted-block schedule stratified by investigational site. Subjects will be randomized to receive either RBCs derived from Mirasol-treated whole blood followed by conventional RBCs, or to receive conventional RBCs followed by RBCs derived from Mirasol-treated whole blood.