Comparison of Hemanext ONE® System and Conventional Red Blood Cell Transfusion
ConditionHematologic Neoplasms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHemanext
About this trial
The overall objective of this study is to collect preliminary effectiveness and safety data on the transfusion of hypoxic RBCs, manufactured with the Hemanext ONE device, in patients with hematological malignancies. The Hemanext ONE device received CE mark in April 2021.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female aged 18 or older
Patients with a documented diagnosis of a haematological malignancy requiring chronic transfusions.
If MDS patient, Have low risk or intermediate risk MDS per either IPSS-R (https://www.mds-foundation.org/ipss-r-calculator/) or IPSS-M (IPSS-M Risk Calculator (mds-risk-model.com))
If MDS patient, a bone marrow aspirate completed within the 6 months prior to study enrolment, and which did not show progression to higher risk MDS
Disqualifiers
Have a life expectancy of less than 1 year
Have palpable splenomegaly (more than 3 cm below the mid clavicular line)
Have other associated causes of anemia (including auto-immune hemolysis or active hemorrhage, or progression to acute leukemia)
If prescribed erythropoiesis affecting disease modifying agents (e.g. G-CSF, erythropoietin), have not been on a stable dose for 90 days
Trial design
Design model
Crossover
Treatments tested in this trial
Hemanext ONE system
DeviceHypoxic red blood cells
Conventional RBCs
DeviceConventional manufactured Red blood cells
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: A - Hemanext ONE systemExperimental treatment 1 intervention
Group B: B - Conventional RBCsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of RBCs units per unit of time
The difference in the total number of hypoxic RBCs units per unit of time transfused to MDS patients during the study period compared to the total number of conventional RBCs units per unit of time transfused.
Time frame
Through study completion, an average of 15 monthsSecondary outcomes
1
Volume of blood transfused
The mean volume of blood per patient transfused with Hemanext ONE and with standard RBC units will be analyzed and compared
Time frame
Through study completion, an average of 15 months2
Number of transfusion events
Mean number of transfusion events throughout the study period
Time frame
Through study completion, an average of 15 months3
Mean change in key laboratory assessments (hemoglobin)
Mean change in key laboratory assessments (hemoglobin) and average hemoglobin increment after transfusions of hypoxically stored RBCs compared to that with conventionally stored RBCs.
Time frame
Up to 15-60 minutes post transfusion, up to day 7, up to pre-transfusion of first washout visit (at 6 months), up to transfusion on the final transfusion visit (at 15 months)4
Mean change in key laboratory assessments (hematocrit)
Mean change in key laboratory assessments (hematocrit) after transfusions of hypoxically stored RBCs compared to that with conventionally stored RBCs.
Time frame
Up to 15-60 minutes post transfusion, up to day 7, up to pre-transfusion of first washout visit (at 6 months), up to transfusion on the final transfusion visit (at 15 months) Source ClinicalTrials.gov