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

A vizsgálat adatai

Ki végzi

University Research Institute for the Study of Genetic & Malignant Disorders in Childhood

Azonosító

NCT07055503

A regiszteradat frissítve

2025. december 17.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

The αO2-PRBC.Thal Study on the Use of Hemanext One® RBC Storage System for Blood Transfusion Support on Transfusion-dependent Thalassemia

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.

Bevonási feltételek: 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.

Kizáró feltételek: Subject has had positive Coombs (antiglobulin) test anytime during the 6 months prior to enrollment; 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; Subject has currently or has a history of any significant medical condition, laboratory abnormality, or psychiatric illness; The presence of any of the following will exclude a subject from enrollment:; Subject is scheduled to undergo or has recently (in the last 6 months) undergone splenectomy.

ClinicalTrials.gov NCT07055503