Quality of Life-Guided Transfusion in Refractory MDS or AML
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nice
About this trial
Patients with refractory myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) in exclusive palliative care frequently receive red blood cell transfusions based on hemoglobin thresholds, despite limited evidence of clinical benefit in this setting.
This prospective randomized study compares a standard hemoglobin-based transfusion strategy to a quality-of-life-guided strategy using the EQ-5D-5L questionnaire, with the aim of reducing transfusion burden while maintaining patient safety and quality of life.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Red blood cell transfusions based on EQ-5D-5L questionnaire
Treatment groups
52 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov