Transfusion in Lower Risk MDS Patients: Predictors of Adequacy of Transfusion and Quality of Life Changes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Prediction of Quality of Life (QoL) improvement, assessed by an increase in 5 points or more in the QUALMs scale
研究概览
简要总结
Observational study to evaluate changes in quality of life (QoL) in patients diagnosed with low risk MDS who are red blood cell (abc) transfusion dependent.
Changes in QoL will be correlated with patient cardiorespiratory function. Cardiac biomarkers and plasma cytokines will also be evaluated.
详细描述
At inclusion and before red blood cell (rbc) transfusion, patients cardiorespiratory function will be evaluated with an ergospirometer
Likewise, before and after rbc transfusion, patients will be asked to complete the QUALMS, a QoL instrument which will be supplied by Dr. Gregory Abel at Dana-Farber in the U.S., who led its development team.
Before and after rbc transfusion, hemoglobin, pretrasfusional hemoglobin, pre and post cardiac biomarkers troponin and NTproBNP will be collect.Pre and post serum and plasma will also be collected for cytokine analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Prediction of Quality of Life (QoL) improvement, assessed by an increase in 5 points or more in the QUALMs scale
时间窗: We expect to obtain results in one year from the beginning of the study
To design a score that help to identify which patients benefit from red blood cell Transfusion in terms of QoL improvement
次要结局
- Changes in QoL before and after transfusion(QoL will be asses the day of transfusion and seven days after)
研究者
Teresa Bernal del Castillo
Principal Investigator, MD, PHD
Fundación para la Investigación Biosanitaria del Principado de Asturias