Transfusion of Red Cells in Hematopoietic Stem Cell Transplantation: The TRIST Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 8
- 主要终点
- Quality of Life (QOL)/Function based on the FACT-BMT scale
研究概览
简要总结
Transfusion of red blood cells (RBCs) is important for the care of patients undergoing stem cell transplantation. Stem cell transplants are used to treat blood cancers and bone marrow disorders. This involves the use of high doses of chemotherapy and/or radiation to kill cancer cells; but this damages the marrow and blood system. Blood stem cells are transplanted by infusing into the recipient and blood counts recover over 2-3 weeks. Before bone marrow recovery, RBCs are needed to support the patient. Higher hemoglobin in these high risk patients may have benefits such as better energy and organ function. However, research in other areas of medicine suggests that a higher red cell count may be dangerous. Taken together, it is unclear whether having a lower or higher red cell count is better for patients having a blood stem cell transplant. The investigators plan to study this by randomly assigning patients having a transplant to be transfused with RBCs either at a higher or lower hemoglobin level. In this way, the investigators will be able to accurately find out if there are any benefits or harms in having a lower or higher red cell count during the recovery period after blood stem cell transplantation.
详细描述
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Males or females aged 18 years or older who are undergoing either an autologous or allogeneic HSCT.
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The indications for HSCT may include, but not limited to the following diseases :
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Acute Leukemia, myeloid, lymphoid or biphenotypic in 1st, 2nd remission or in relapse
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Chronic Myeloid Leukemia in chronic, accelerated or blast phase
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Chronic Lymphocytic Leukemia
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Myelodysplastic Syndrome
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Myeloproliferative Disorder
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Lymphoma
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Myeloma
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All study patients must provide consent at least 1 day prior to scheduled HSCT and provide written informed consent.
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
- •Patients are aged 16-70 undergoing either an autologous or allogeneic HSCT for any hematologic malignancy
排除标准
- •Pregnant or lactating at the time of enrollment
- •Already received red cell transfusion after HSCT but prior to enrollment
- •Unable/unwilling to provide informed consent.
- •Patients receiving HSCT for non-malignancy
结局指标
主要结局
Quality of Life (QOL)/Function based on the FACT-BMT scale
时间窗: 3 years
The FACT consists of 5 subscales that measure physical well-being, functional well-being, social/family well-being and emotional well-being. The BMT subscale of the FACT includes additional items specifically designed to test quality of life and symptoms specific to BMT patients.
次要结局
- Transplant Related Mortality(100 days)
- Platelet Transfusion(100 days)
- Red Cell Transfusion(100 days)
- Time to Non-relapse Mortality(100 days)
- Serious Infections(100 days)
- Economic Evaluation/Quality of Life(100 days)
- NCI Toxicity Scale(100 days)
- Acute Graft Versus Host Disease(100 days)
- Bleeding(100 days)