Quality of Life-based Transfusion in Refractory MDS or AML Under Advanced Palliative Care and Supportive Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Number of Red Blood Cell Transfusions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Hemoglobin-Based Transfusion Strategy
Red blood cell transfusions are performed according to standard hemoglobin thresholds (Hb <7 g/dL, or <8 g/dL in patients with cardiovascular comorbidities). Standard of care arm
Quality of Life-Guided Transfusion Strategy
Red blood cell transfusions are performed when a clinically significant deterioration (≥1 level decrease in at least one EQ-5D-5L domain compared to baseline) is observed
干预措施: Red blood cell transfusions based on EQ-5D-5L questionnaire (Other)
结局指标
主要结局
Number of Red Blood Cell Transfusions
时间窗: 2 months
Total number of red blood cell units transfused during the 2-month follow-up period.
次要结局
- Quality of Life (EQ-5D-5L)(from baseline to 1 month and 2 months.)
- Overall Survival(from inclusion to 2 months)