The overall objective of this study is to evaluate the effectiveness and safety of transfusing hypoxic red blood cells manufactured with the Hemanext ONE system in patients with sickle cell anemia. The Hemanext ONE device was cleared through the De Novo process in September 2023.
Male or female at least 7 years of age;
Are able to provide informed consent, and assent as applicable, to participate in the study;
Diagnosis of Sickle Cell Anemia (SCA) (HbSS, HbSβ0 thalassemia) with participation in a chronic transfusion program and have undergone regular transfusions during at least 6 months prior to Screening;
Have had an average interval of at least 14 days between RBC transfusions over the past 6 months;
Are not exclusively transfused at the site;
Have a diagnosis of HbSC disease, HbSβ+ thalassemia or another SCD variant (excluding HbSS and HbSβ0 thalassemia)
Are routinely transfused with washed, packed RBC units;
Have received hemoglobin inducers (e.g. erythropoietin) in the 30 days prior to Screening;
Crossover
Hemanext ONE System
DeviceHypoxic red blood cells
Conventional RBCs
DeviceConventional red blood cells
%HbA Rate of Decline
The primary objective is to evaluate the decreased rate of decline of %HbA between post-transfusion RCE and the subsequent pre-transfusion RCE over 6 transfusion cycles in the hypoxic RBC group compared to the conventional group.
Volume of blood transfused
The mean volume of blood per patient transfused with hypoxic RBCs and with standard RBC units will be analyzed and compared
HgbS Rate of Increase
Average rate of increase of the HgbS measurement between automated red cell exchange (RCE) of hypoxic RBCs compared to conventional RBCs.
Incidence rate of vaso-occlusive crisis.
Incidence rate of vaso-occlusive crisis events through the duration of the study
Incidence rate of acute chest syndrome
Incidence rate of acute chest syndrome events accompanied by fever and/or respiratory symptoms through the duration of the study
Hemoglobin increment from each transfusion
The hemoglobin increment from each transfusion will be determined by calculating the difference between the patient's post-transfusion and pre-transfusion hemoglobin. It will then be corrected for estimated patient blood volume and the amount of Hb transfused
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Hemanext
Lead sponsor
Emory University
Collaborator
University of Connecticut
Collaborator
University of Pittsburgh Medical Center
Collaborator
Johns Hopkins University
Collaborator
University of Illinois at Chicago
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
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