Comparison of Hemanext ONE® System and Conventional Red Blood Cell Transfusion (NCT06685848) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Comparison of Hemanext ONE® System and Conventional Red Blood Cell Transfusion
United States, Norway24 participantsStarted 2024-11-29
Plain-language summary
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 and marketing authorization through the FDA De Novo process in September 2023.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 3…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of RBCs units per unit of time
Timeframe: Through study completion, an average of 15 months