Use of the Hemanext One® Hypoxic Red Blood Cell Storage System for Transfusion in Thalassemia Patients

NCT07055503 | Enrolling By Invitation

• 1 other identifier: αO2-PRBC.Thal
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Transfusion-dependent thalassemia (TDT) requires lifelong, regular red blood cell (RBC) transfusions. Conventionally stored RBCs develop biochemical and structural "storage lesions," driven largely by oxidative stress, which may reduce post-transfusion survival and contribute to anemia, hemolysis, metabolic abnormalities, and iron overload. Hypoxic storage has emerged as a strategy to mitigate oxidative deterioration and preserve RBC quality. The Hemanext One® system allows processing and storage of RBCs under hypoxic conditions (low oxygen and carbon dioxide). Early studies have shown improved metabolic preservation compared with standard storage. In Greece, and specifically at the National Center for Blood Transfusion (EKEA), hypoxically stored RBCs have already been introduced into routine transfusion practice for selected TDT patients, independently of this study. This study is observational and does not assign or provide Hemanext-processed RBCs. Instead, it aims to systematically evaluate the hematologic, metabolic, and clinical impact of receiving hypoxically stored RBCs in adult TDT patients who are already being transfused with Hemanext units as part of their clinical care. The study includes a 12-week baseline period based on conventional transfusions, followed by a treatment phase of at least 3 months during which patients continue receiving Hemanext-processed RBCs as provided by EKEA; the treatment phase may be extended for each participant up to the study-wide data cut-off date. Informed consent is obtained before any study-related data collection. The primary objective is to compare transfusion burden (cc/kg) between baseline conventional RBCs and hypoxically stored RBCs administered in routine care. Secondary objectives include changes in pre-transfusion hemoglobin, total hemoglobin mass, hemolysis and erythropoiesis markers, metabolic indicators, iron overload parameters, quality of life, and safety outcomes. Findings will provide real-world evidence on the feasibility and clinical impact of hypoxically stored RBCs in chronically transfused patients.

Conditions

Blood Transfusion; Transfusion-dependent Beta-Thalassemia

Keywords

Red Blood Cell Transfusion; Anemia; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in RBC transfusion burden

  Changes from baseline in RBC transfusion burden. Significant changes are defined as a difference of \>20% from baseline, corresponding to at least 1 unit per 24 weeks.

  Up to 6 months

Secondary Outcomes (11)

• Change from baseline in pre-transfusion hemoglobin.

  Up to 6 months

• Change from baseline in fatigue-related quality of life using FACIT-F Version 4

  Week 13, Week 24

• Healthcare resource utilization

  Up to 6 months

• Change from baseline in reticulocyte count

  Up to 6 months

• Change from baseline in total bilirubin levels

  Up to 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adults aged 18 years or older diagnosed with β-transfusion dependent thalassemia (TDT) who require regular red blood cell (RBC) transfusions, defined as receiving at least 6 units of RBCs over 24 weeks without a transfusion-free interval longer than 42 days. Participants must have a documented transfusion history and be on a stable chelation therapy regimen for at least six months prior to enrollment. Patients receiving stable doses of chronic therapies, including hydroxyurea, are eligible. Individuals with significant medical, laboratory, or psychiatric conditions that may interfere with study participation, or with a positive Coombs test within six months prior to enrollment, are excluded.

You may qualify if:

• Subjects must satisfy the following criteria to be enrolled in the study:
• Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
• Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
• Subject has documented diagnosis of β- transfusion dependent thalassemia, defined as ect: ≥ 6 RBC units/24 weeks and no transfusion-free period for ≥ 42 days during the 24 weeks prior enrollment.
• Transfusion history (including units or cc) for at least 6 months prior to enrollment needs to be available.
• Subject is on chelation therapy and a fairly stable dose for at least 6 months prior to enrollment.
• Chronic therapies (including hydroxyurea) are allowed as long as the medication dose has been stable for at least 6 months prior to enrollment.
• Having been exposed to PRBC transfusions prepared with the Hemanext One processing system

You may not qualify if:

• The presence of any of the following will exclude a subject from enrollment:
• Subject has currently or has a history of any significant medical condition, laboratory abnormality, or psychiatric illness.
• Subject has had positive Coombs (antiglobulin) test anytime during the 6 months prior to enrollment.
• Subject is scheduled to undergo or has recently (in the last 6 months) undergone splenectomy.
• Use of luspatercept during the period of 6 months prior to enrollment and during the trial is not allowed.
• Participation in an interventional clinical trial or use of experimental medications during the period of 6 months prior to enrollment and during the trial is not allowed.

Sponsors & Collaborators

• Hemanext: collaborator
• Laikο General Hospital, Athens: collaborator
• University Research Institute for the Study of Genetic & Malignant Disorders in Childhood: lead

Study Sites (1)

Aghia Sophia Children's Hospital

Athens, Attica, 11527, Greece

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood samples will be collected and retained for future biochemical, metabolic, and hematological analyses. Samples may be used to assess markers related to hemolysis, erythropoiesis, oxidative stress, and red blood cell metabolism. No DNA will be extracted from the retained samples. All samples will be coded and stored under secure conditions in compliance with data protection regulations.

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Antonis Kattamis, Professor

  National and Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatric Hematology/Oncology Head, Division of f Pediatric Hematology/Oncology First Department of Pediatrics - National & Kapodistrian University of Athens, 'Aghia Sophia' Children's Hospital

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: July 9, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

GR (1)