Study of Red Blood Cell Transfusion Triggers in Patients Undergoing Hematopoietic Stem Cell Transplantation (TRIST)
2016年10月11日 更新者:Ottawa Hospital Research Institute
Transfusion of Red Cells in Hematopoietic Stem Cell Transplantation: The TRIST Study
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.
研究概览
详细说明
- Males or females aged 18 years or older who are undergoing either an autologous or allogeneic HSCT.
The indications for HSCT may include, but not limited to the following diseases :
- Acute Leukemia, myeloid, lymphoid or biphenotypic in 1st, 2nd remission or in relapse
- Chronic Myeloid Leukemia in chronic, accelerated or blast phase
- Chronic Lymphocytic Leukemia
- Myelodysplastic Syndrome
- Myeloproliferative Disorder
- Lymphoma
- Myeloma
- All study patients must provide consent at least 1 day prior to scheduled HSCT and provide written informed consent.
研究类型
介入性
注册 (实际的)
300
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Ontario
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Hamilton、Ontario、加拿大、L8N 3Z5
- Hamilton Health Sciences Centre
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London、Ontario、加拿大、N6A 5A5
- London Health Sciences Centre, University Hospital
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Ottawa、Ontario、加拿大、K1H 8L6
- The Ottawa Hospital
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Saskatchewan
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Saskatoon、Saskatchewan、加拿大、S7N 4H4
- Saskatchewan Cancer Centre
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients are aged 16-70 undergoing either an autologous or allogeneic HSCT for any hematologic malignancy
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Restrictive Red blood cell Transfusion
Transfusion Trigger of 70g/L with an aim to maintain Hemoglobin between 80-90g/L
|
Transfusion of Red blood cells to based on daily complete blood count
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有源比较器:Liberal Red blood Cell Transfusion
Transfusion Trigger of 90g/L with an aim to maintain Hemoglobin between 100-110g/L
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Transfusion of Red blood cells to based on daily complete blood count
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Quality of Life (QOL)/Function based on the FACT-BMT scale
大体时间: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.
|
3 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Transplant Related Mortality
大体时间:100 days
|
100 days
|
|
Red Cell Transfusion
大体时间:100 days
|
100 days
|
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Platelet Transfusion
大体时间:100 days
|
100 days
|
|
Acute Graft Versus Host Disease
大体时间:100 days
|
100 days
|
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Bleeding
大体时间:100 days
|
Grade 3 or 4 by WHO scale
|
100 days
|
Serious Infections
大体时间:100 days
|
All grade 4 and 5 infections (according to the CTCAE v.4)
|
100 days
|
Time to Non-relapse Mortality
大体时间:100 days
|
100 days
|
|
Economic Evaluation/Quality of Life
大体时间:100 days
|
EQ-5D
|
100 days
|
NCI Toxicity Scale
大体时间:100 days
|
100 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员:Jason Tay, MD FRCPC MSc、Ottawa Hospital Research Institute
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Tay J, Tinmouth A, Fergusson D, Allan D. Transfusion of red cells in hematopoietic stem cell transplantation (TRIST): study protocol for a randomized controlled trial. Trials. 2011 Sep 21;12:207. doi: 10.1186/1745-6215-12-207.
- Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Dorée C, Hébert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12:CD002042. doi: 10.1002/14651858.CD002042.pub5. Review.
- Tay J, Allan DS, Chatelain E, Coyle D, Elemary M, Fulford A, Petrcich W, Ramsay T, Walker I, Xenocostas A, Tinmouth A, Fergusson D. Liberal Versus Restrictive Red Blood Cell Transfusion Thresholds in Hematopoietic Cell Transplantation: A Randomized, Open Label, Phase III, Noninferiority Trial. J Clin Oncol. 2020 May 1;38(13):1463-1473. doi: 10.1200/JCO.19.01836. Epub 2020 Feb 21.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年3月1日
初级完成 (实际的)
2016年10月1日
研究完成 (实际的)
2016年10月1日
研究注册日期
首次提交
2010年10月13日
首先提交符合 QC 标准的
2010年11月8日
首次发布 (估计)
2010年11月9日
研究记录更新
最后更新发布 (估计)
2016年10月12日
上次提交的符合 QC 标准的更新
2016年10月11日
最后验证
2016年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.