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Hematologic NeoplasmsNCT06685848

Comparison of Hemanext ONE® System and Conventional Red Blood Cell Transfusion

A study testing Hemanext ONE system and Conventional RBCs in people with Hematologic Neoplasms, run by Hemanext at 2 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hematologic Neoplasms
What is being tested?
Hemanext ONE system and Conventional RBCs
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
2 sitesin 2 countries
Study dates
29 Nov 2024to Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Duke University Health System

    Durham, North Carolina, 27705

Other trials in United States

Norway1 site

  • Haukeland University Hospital

    Bergen, 5021

Other trials in Norway

About this study

Official title: 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

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.

Read the detailed description

The primary objective is to evaluate whether the total number of hypoxically stored red blood cell (RBCs) units per unit of time transfused in patients with haematologic malignancies, requiring chronic blood transfusion therapy, is non-inferior to the total number of units of conventionally stored RBCs per unit of time transfused.

Secondary objectives include the following:

  1. Analysis of volume of blood transfused
  2. Analysis of number of transfusion events throughout the study period
  3. Key laboratory assessments (hemoglobin and hematocrit) and average hemoglobin increment after transfusions of hypoxically stored RBCs compared to that with conventionally stored RBCs
  4. Evaluation of Quality of Life (QoL)
  5. Change in serum ferritin
  6. Safety assessment
Being tested
Hemanext ONE system, Conventional RBCs
Keywords
Transfusion, Red Blood Cells, Hypoxic
Medical subject headings
Hematologic Neoplasms, Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hemanext ONE systemDevice

    Hypoxic red blood cells

  • Conventional RBCsDevice

    Conventional manufactured Red blood cells

Study groups in NCT06685848
Study groupRoleWhat they receive
A - Hemanext ONE systemExperimentalHypoxic RBCs
Receives: Device: Hemanext ONE system
B - Conventional RBCsActive comparatorConventional RBCs
Receives: Device: Conventional RBCs

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Through study completion, an average of 15 months

Secondary outcomes (7)

  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

    Measured: Through study completion, an average of 15 months

  2. Number of transfusion events

    Mean number of transfusion events throughout the study period

    Measured: Through study completion, an average of 15 months

  3. 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.

    Measured: 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.

    Measured: 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)

  5. Mean change in QoL

    Mean change in QoL as assessed by the EORTC QLQ-C30 (EORTC Quality of Life Questionnaire).

    Scores from 1-4 (where 1 indicates a better outcome and 4 indicates a worse outcome):

    1. Not at all
    2. A little
    3. Quite a bit
    4. Very Much

    Additionally, a rating from 1-7, where 1 is "Very poor" and 7 is "Excellent"

    Measured: At the end of first transfusion cycle at 6 months and at study exit (at 15 months)

  6. Mean change in serum ferritin

    Mean change from baseline in serum ferritin (assessment during baselines 1 and 2 (first pre-transfusion visit of each arm) to pre-transfusion of first washout visit and pre-transfusion of the final visit).

    Measured: At the end of first transfusion cycle at 6 months and at study exit (at 15 months)

  7. Safety assessment in terms of frequency of adverse event reactions and device deficiencies.

    Safety assessment in terms of frequency of adverse event reactions and device deficiencies.

    Measured: Through study completion, an average of 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2024
  2. Study start29 Nov 2024
  3. Primary completionMay 2028 (estimated)
  4. Study completionAug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06685848
Sponsor's protocol ID
PRO-CLIN-0015
Status last verified
Aug 2026
First submitted
5 Nov 2024
Last updated
14 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Hemanext ONE system and Conventional RBCs in people with Hematologic Neoplasms, run by Hemanext at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of RBCs units per unit of time (time frame: Through study completion, an average of 15 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06685848.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.

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