Actively Recruiting
Multi-Center, Randomized, Controlled Cross-Over Study to Evaluate Safety and Effectiveness of Hypoxic RBCs Processed With the Hemanext ONE System vs Conventional RBCs in Patients With Transfusion-Dependent Haematological Malignancies
Led by Hemanext · Updated on 2026-01-07
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and preliminary effectiveness of transfusing hypoxically stored red blood cells (RBCs) processed using the Hemanext ONE device in patients with hematological malignancies who require chronic blood transfusions. The study aims to determine if the number of hypoxic RBC units transfused over time is not inferior to that of conventional RBC units. Secondary goals include assessing blood volume transfused, transfusion frequency, blood lab values, quality of life, serum ferritin levels, and safety. Participants will receive transfusions of either hypoxic RBCs processed by the Hemanext ONE system or conventional RBCs in a randomized, controlled cross-over design. The study compares these two types of blood products delivered over an average period of 15 months. The Hemanext ONE device has received CE mark approval, and this study evaluates its performance specifically in transfusion-dependent patients with hematologic cancers. Throughout the study, participants will have regular monitoring of transfusion events, blood volume transfused, hemoglobin and hematocrit measurements after transfusions, quality of life assessments, and serum ferritin levels at set time points including 6 and 15 months. Safety is evaluated by tracking adverse reactions and device issues. The total participation duration averages 15 months, during which detailed laboratory and clinical assessments support evaluation of the devices and patient outcomes.
CONDITIONS
Brief 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
- Documented diagnosis of a haematological malignancy requiring chronic transfusions
- For MDS patients: low or intermediate risk per IPSS-R or IPSS-M
- Bone marrow aspirate within 6 months prior to enrollment showing no progression to higher risk MDS (for MDS patients)
- RBC transfusion dependence (at least 2 RBC units per 8 weeks during the last 16 weeks)
- Baseline RBC transfusion threshold of 9 g/dL
- ECOG performance status less than 3
- Signed informed consent and willingness to comply with study visits and procedures
- Stable dose of Iron Chelation Therapy for at least 3 months prior to screening (if applicable)
You will not qualify if you...
- Life expectancy less than 1 year
- Palpable splenomegaly more than 3 cm below the mid clavicular line
- Other causes of anemia such as autoimmune hemolysis, active hemorrhage, or progression to acute leukemia
- Unstable or non-stable use of erythropoiesis affecting agents within 90 days
- Current use of Luspatercept or other investigational erythropoiesis agents
- Severe renal insufficiency with creatinine clearance below 30 ml/min
- Lung disease with hypoxia or oxygen dependency
- Severe coronary artery disease or severe heart failure with ejection fraction less than 30%
- History of active cancer in the past 3 years except certain local cancers
- History of allo-immunization not manageable by local blood bank
- Female of child-bearing potential who is pregnant, planning pregnancy in next 14 months, or breastfeeding
- Under guardianship or curatorship
- Currently in another interventional study evaluating erythropoiesis agents
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 15 months
Participants receive transfusions of hypoxic red blood cells processed with the Hemanext ONE system and conventional red blood cells in a randomized cross-over design to compare safety and effectiveness.
Regular transfusion visits throughout the study period
Duration - Up to 15 months
Participants are monitored for safety and effectiveness outcomes, including laboratory assessments, quality of life, and serum ferritin levels, during and after transfusions.
Assessments at transfusion visits and study exit
Trial Site Locations
Total: 1 location
1
Haukeland University Hospital
Bergen, Norway, 5021
Actively Recruiting
Research Team
J
Jill Badgasarian
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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