New blood storage method could mean fewer transfusions for thalassemia patients
NCT ID NCT07055503
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether storing red blood cells in a low-oxygen environment (called hypoxic storage) can improve transfusion care for adults with transfusion-dependent beta-thalassemia. Participants already receiving these specially stored blood cells as part of their routine care will be observed for at least 3 months. The goal is to see if this method reduces the amount of blood needed and improves quality of life.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria Subjects must satisfy the following criteria to be enrolled in the study: 1. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF). 2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted. 3. 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. 4. Transfusion history (including units or cc) for at least 6 months prior to enrollment needs to be available. 5. Subject is on chelation therapy and a fairly stable dose for at least 6 months prior to enrollment. 6. Chronic therapies (including hydroxyurea) are allowed as long as the medication dose has been stable for at least 6 months prior to enrollment. 7. Having been exposed to PRBC transfusions prepared with the Hemanext One processing system Exclusion Criteria The presence of any of the following will exclude a subject from enrollment: 1. Subject has currently or has a history of any significant medical condition, laboratory abnormality, or psychiatric illness. 2. Subject has had positive Coombs (antiglobulin) test anytime during the 6 months prior to enrollment. 3. Subject is scheduled to undergo or has recently (in the last 6 months) undergone splenectomy. 4. Use of luspatercept during the period of 6 months prior to enrollment and during the trial is not allowed. 5. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Aghia Sophia Children's Hospital
Athens, Attica, 11527, Greece
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Other studies related to the condition(s) this trial covers.
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