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
Qualifiers
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
Treatments tested in this trial
- Hemanext ONE system
- Conventional RBCs
Treatment groups
24 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov