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Quality of Life-Guided Transfusion in Refractory MDS or AML

ConditionsMDSAML, AdultAnemia
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Red blood cell transfusions based on EQ-5D-5L questionnaire

    Other intervention

    Red blood cell transfusions are administered based on patient-reported quality-of-life assessments using the EQ-5D-5L questionnaire, collected weekly. A transfusion is performed when a deterioration of at least one level in any EQ-5D-5L dimension is observed.

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: Hemoglobin-Based Transfusion StrategyNo intervention 0 interventions
Group B: Quality of Life-Guided Transfusion StrategyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Red Blood Cell Transfusions

Total number of red blood cell units transfused during the 2-month follow-up period.

Time frame
2 months

Secondary outcomes

1

Quality of Life (EQ-5D-5L)

Change in quality-of-life scores

Time frame
from baseline to 1 month and 2 months.
2

Overall Survival

Survival status

Time frame
from inclusion to 2 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire de Nice

Lead sponsor

Source ClinicalTrials.gov
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