Quality of Life-Guided Transfusion in Refractory MDS or AML

This is a prospective, single-center, randomized interventional study conducted in patients with transfusion-dependent refractory MDS or AML receiving exclusive palliative care. Palliative Care

Patients are randomized to either a standard transfusion strategy based on hemoglobin thresholds or a quality-of-life-guided strategy in which red blood cell transfusions are triggered by a clinically significant deterioration in EQ-5D-5L score.

The study aims to evaluate whether a quality-of-life-guided transfusion strategy can safely reduce the number of red blood cell transfusions without negatively impacting patient-reported outcomes.

Inclusion criteria

• Adults aged 18 years and older.
• Diagnosis of refractory MDS or AML, receiving palliative care only.
• Anaemia with haemoglobin ≤ 8 g/dl at inclusion (or ≤ 9 g/dl if associated with cardiovascular disease).
• Transfusion dependency, defined as requiring more than 2 GR transfusions every 8 weeks.
• No vitamin B9, vitamin B12 or iron deficiency.
• Ability to understand and sign the informed consent form.
• Ability to comply with the schedule of visits and other protocol requirements.

Non inclusion Criteria:

• Previous malignant disease other than MDS or AML (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast).
• Active uncontrolled infection (hepatitis B or C, HIV).
• Use of G-CSF.
• Confirmed neurocognitive disorders (based on prior diagnosis or clinical assessment by the investigator) impairing comprehension, consent or the ability to reliably complete the EQ-5D-5L questionnaire.
• Active uncontrolled heart disease.
• Active haemolytic anaemia.
• Recent major surgery.
• Life-threatening complications of MDS/AML.
• Presence of another serious or unstable disease which, in the investigators' opinion, would make participation in the study inappropriate or risky for the patient's safety.
• Vulnerable individuals.

Exclusion criteria

• Immediate severe complications related to MDS/AML, such as uncontrolled bleeding, pneumonia with hypoxia or shock, or severe disseminated intravascular coagulopathy.
• Withdrawal of the patient's voluntary informed consent.