Actively Recruiting
Comparison of Hemanext ONE® System and Conventional Red Blood Cell Transfusion
Led by Hemanext · Updated on 2026-01-07
24
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparison of Hemanext ONE® System and Conventional Red Blood Cell Transfusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Have RBC transfusion dependence (at least 2 RBC units /8 weeks during the last 16 weeks)
- Baseline RBC transfusion threshold of 9 g/dL
- ECOG (Eastern Cooperative Oncology Group) performance status < 3
- Have signed the informed consent form and are willing to comply with the study visits and procedures
- If on Iron Chelation Therapy, have been on a stable dose for ≥3 months prior to screening
You will not qualify if you...
- 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
- Is currently taking Luspatercept or other investigational erythropoiesis affecting disease modifying agent
- Have severe renal insufficiency with creatinine clearance (MDRD or CKD EPI) below 30ml/min
- Have lung disease with hypoxia or oxygen-dependent
- Have severe coronary artery disease (including unstable angina or recent myocardial infraction) or severe heart failure (left ventricular ejection fraction less than 30%)
- Have a history of cancer active in the previous 3 years, except local cervix cancer, or basal cell cutaneous carcinoma
- Have a history of allo-immunization other than rhesus Kell that cannot be managed by the local blood bank
- Are a female of child-bearing potential that is pregnant, planning to become pregnant in the next 14 months or breastfeeding
- Are a patient under guardianship or curatorship
- Are currently participating in another interventional study evaluating an erythropoiesis affecting disease modifying agent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Haukeland University Hospital
Bergen, Norway, 5021
Actively Recruiting
Research Team
J
Jill Badgasarian
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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