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

NCT ID: NCT06685848

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-29
• Study Completion Date: 2026-12-15

Brief 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.

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

Conditions

Hematologic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

A - Hemanext ONE system

Hypoxic RBCs

Group Type: EXPERIMENTAL

Hemanext ONE system

Intervention Type: DEVICE

Hypoxic red blood cells

B - Conventional RBCs

Conventional RBCs

Group Type: ACTIVE_COMPARATOR

Conventional RBCs

Intervention Type: DEVICE

Conventional manufactured Red blood cells

Interventions

Hemanext ONE system

Hypoxic red blood cells

Intervention Type: DEVICE

Conventional RBCs

Conventional manufactured Red blood cells

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hemanext

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Håkon Reikvam, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Locations

Haukeland University Hospital

Bergen, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Jill Badgasarian

Role: CONTACT

jill.bagdasarian@hemanext.com

(781) 301-7474

Facility Contacts

Hakon Reikvam, PhD, MD

Role: primary

hakon.reikvam@uib.no

+4791 66 70 94

Other Identifiers

PRO-CLIN-0015

Identifier Type: -

Identifier Source: org_study_id