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

August 12, 2026 updated by: Hemanext

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Norway
      • Bergen, Norway, 5021
        • Haukeland University Hospital
  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: A - Hemanext ONE system
Hypoxic RBCs
Device: Hemanext ONE system
Hypoxic red blood cells
Active Comparator: B - Conventional RBCs
Conventional RBCs
Device: Conventional RBCs
Conventional manufactured Red blood cells

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of RBCs units per unit of time
Time Frame: Through study completion, an average of 15 months
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.
Through study completion, an average of 15 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Volume of blood transfused
Time Frame: Through study completion, an average of 15 months
The mean volume of blood per patient transfused with Hemanext ONE and with standard RBC units will be analyzed and compared
Through study completion, an average of 15 months
Number of transfusion events
Time Frame: Through study completion, an average of 15 months
Mean number of transfusion events throughout the study period
Through study completion, an average of 15 months
Mean change in QoL
Time Frame: At the end of first transfusion cycle at 6 months and at study exit (at 15 months)

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"
At the end of first transfusion cycle at 6 months and at study exit (at 15 months)
Mean change in serum ferritin
Time Frame: At the end of first transfusion cycle at 6 months and at study exit (at 15 months)
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).
At the end of first transfusion cycle at 6 months and at study exit (at 15 months)
Safety assessment in terms of frequency of adverse event reactions and device deficiencies.
Time Frame: Through study completion, an average of 15 months
Safety assessment in terms of frequency of adverse event reactions and device deficiencies.
Through study completion, an average of 15 months
Mean change in key laboratory assessments (hemoglobin)
Time Frame: 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)
Mean change in key laboratory assessments (hemoglobin) and average hemoglobin increment after transfusions of hypoxically stored RBCs compared to that with conventionally stored RBCs.
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)
Mean change in key laboratory assessments (hematocrit)
Time Frame: 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)
Mean change in key laboratory assessments (hematocrit) after transfusions of hypoxically stored RBCs compared to that with conventionally stored RBCs.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hemanext

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Håkon Reikvam, PhD, MD, Haukeland University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 29, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO-CLIN-0015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings