NCT04544540尚未招募不适用
One Versus Two Unit Transfusions in Oncology Patients - The OTTOP Trial: A Randomized Open-label Pragmatic Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 450
- 主要终点
- number of transfusion episodes in the 1-year after randomization
研究概览
简要总结
The aim of this trial is to determine if the transfusion of one unit of red blood cells to anemic oncology patients results in comparable numbers of transfusion episodes when compared to transfusion of two units of red blood cells.
详细描述
The aim of this trial is to determine if administration of one unit of red blood cells to anemic oncology patients is non-inferior to the administration of two units of red blood cells in terms of the number of annual transfusion episodes. If demonstrated, our findings will cut the total transfusion episode time in half and avoid exposure to an additional unit of red blood cells while freeing up scarce hospital resources.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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 over 18 years of age with solid tumour (non-hematologic) malignancy undergoing chemotherapy
- •Requiring a red blood cell transfusion as determined by their treating oncologist
排除标准
- •Active bleeding (WHO grade 3 and 4)
- •Known history active hemolysis
- •Inpatient admission
- •Refusal to receive red blood cell transfusion
- •Unwilling or unable to provide informed consent
结局指标
主要结局
number of transfusion episodes in the 1-year after randomization
时间窗: 1 year
次要结局
- Duration of outpatient transfusion episodes (time in the medical day care unit)(1 year)
- Hemoglobin levels at the time of subsequent chemotherapy treatments(1 year)
- Difference in Pre- and post-transfusion Edmonton Symptom Assessment Scale where available(1 year)
- Hemoglobin levels at the time of next (1st post transfusion) chemotherapy treatment.(1 year)
- Adverse transfusion reactions.(1 year)
- The number of delays in any subsequent chemotherapy treatments.(1 year)
- The length of delays in any subsequent chemotherapy treatments.(1 year)
- Visits to the emergency department and hospitalizations.(1 year)
- Total number of transfusion episodes per patients per month while on chemotherapy.(1 year)
- Post-transfusion hemoglobin increment defined as the difference between the pretransfusion and first hemoglobin measurement occurring after the completion of the transfusion.(1 year)
- Cancer status at 1- year post randomization(1 year)
- Total number of units transfused while on chemotherapy and for entire 1-year follow-up(1 year)
研究者
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