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.
In this Direct-to-Phase II study, Hemanext Inc. will carry out a prospective, multi-center, single-blind, randomized, cross-over study in patients with Sickle Cell Anemia, comparing the efficacy of transfusion of hypoxic red blood cells (HRBCs) to transfusions with conventional RBCs. The primary efficacy objective is to demonstrate an increase in %HbA between red cell exchange transfusions (RCE) of HRBCs compared to conventional RBCs. The increases in %HbA (normal Hb) from RCE will be accompanied by a concomitant decrease in sickle Hb (%HbS). The persistence of %HbA will allow for a decrease in the volume of RBCs transfused with an overall decrease in the number of units consumed, which in turn can result in an increase in time (number of days) between transfusions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
48
Hypoxic red blood cells
Conventional red blood cells
New England Sickle Cell Institute, University of Connecticut
Farmington, Connecticut, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
John Hopkins University School of Medicine
Baltimore, Maryland, United States
%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.
Time frame: Through study completion, an average of 14 months
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
Time frame: Through study completion, an average of 14 months
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.
Time frame: Through study completion, an average of 14 months
Incidence rate of vaso-occlusive crisis.
Incidence rate of vaso-occlusive crisis events through the duration of the study
Time frame: Through study completion, an average of 14 months
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
Time frame: Through study completion, an average of 14 months
Duration (days) of any hospitalization for vaso-occlusive crisis
Mean duration (days) of any hospitalization for vaso-occlusive crisis
Time frame: Through study completion, an average of 14 months
Intravascular hemolysis
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University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Level of intravascular hemolysis (measured with free plasma hemoglobin) between each procedure, before and after each Red Cell Exchange.
Time frame: Through study completion, an average of 14 months
Serum ferritin
Mean change from baseline in serum ferritin
Time frame: Through study completion, an average of 14 months
Changes in hepatic iron content
Mean changes in hepatic iron content
Time frame: Through study completion, an average of 14 months
Change in QoL
Mean change in QoL, as measured by validated QoL questionnaires
Time frame: Through study completion, an average of 14 months
Total hemoglobin before and after RCE
Mean change before and after transfusions of hypoxically stored RBCs compared to that with conventionally stored RBCs.
Time frame: Through study completion, an average of 14 months
Total hematocrit before and after RCE
Mean change before and after transfusions of hypoxically stored RBCs compared to that with conventionally stored RBCs.
Time frame: Through study completion, an average of 14 months
Red Cell Exchange events
Mean number of RCE events over the course of the study
Time frame: Through study completion, an average of 14 months
Safety assessment
Frequency of adverse event reactions and device deficiencies over the course of the study
Time frame: Through study completion, an average of 14 months