Randomised Feasibility Study of Optimal Transfusion Thresholds in Anaemic Cancer Patients Treated With Chemotherapy (HaemOPtimal)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 180
- 试验地点
- 4
- 主要终点
- FACT-G, FACT-An, Numeric Rating Scale on symptoms of anaemia, Performance status
研究概览
简要总结
This an open two-arm interventional randomised feasibility study in anaemic patients treated with chemotherapy. Randomisation is performed between two transfusion thresholds: Haemoglobin < 6.0 mmol/l (9.9 g/dL) versus haemoglobin < 7.1 mmol/l (11.7 g/dL) for female and 8.1 mmol/l (13.4 g/dL) for males.Primary end-point is quality of life
详细描述
Title:
Randomised Feasibility Study of Optimal Transfusion Thresholds in Anaemic Cancer Patients Treated with Chemotherapy (HaemOPtimal)
Background:
Cancer patients treated with chemotherapy very often become anaemic, which have profound negative impact of their quality of life. Blood transfusions can ameliorate symptoms caused by anaemia. Data are lagging with regard to what threshold should be used when offering blood transfusion.
Aim:
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
- •Documented cancer
- •Planned treatment with chemotherapy
- •Age older than 18 years
- •Informed consent
排除标准
- •Heart failure (NYHA 3 and 4)
- •Prior serious complications to blood transfusion
- •Medical conditions that require special considerations for blood transfusion
- •Treatment with erythropoiesis-stimulating agents
结局指标
主要结局
FACT-G, FACT-An, Numeric Rating Scale on symptoms of anaemia, Performance status
时间窗: Before each cylces of chemotherapy in up to six months, and before transfusion, and daily in seven days after transfusion
Patient assessed FACT-G (Functional Assessment of Therapy in General), FACT-An (Functional Assessment of Therapy in Anaemia), Numeric Rating Scale on symptoms of anaemia (fatigue, dizziness, dyspnea, palpitations, headache) and performance status before each cycle of chemotherapy, before transfusion and daily in seven days after transfusion
次要结局
- Safety and transfusion complications(during or after transfusion)
研究者
Morten Sorensen
MD, PhD
Rigshospitalet, Denmark