NCT00202371撤回4 期
Transfusion Effects in Myelodysplastic Patients: Limiting Exposure (Temple)
Sanquin Research & Blood Bank Divisions2 个研究点 分布在 1 个国家开始时间: 2002年7月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- fatigue
研究概览
简要总结
The goal of this study was to compare a restrictive RBC transfusion policy (a Hb transfusion trigger: 7.2 gr/dl) with a more liberal RBC transfusion policy (a Hb transfusion trigger: 9.6 gr/dl) on physical fatigue.
详细描述
The goal of this study was to compare a restrictive RBC transfusion policy (a Hb transfusion trigger of 7.2 gr/dl) with a more liberal RBC transfusion policy (a Hb transfusion trigger of 9.6 gr/dl) on physical fatigue.
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
- Single
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosis myelodysplastic syndrome (primary or secondary) based on cytopenia in at least 1 cell line + dysplasia in 2 cell lines (and no other cause (especially deficiencies)) and a pathologic anatomic diagnosis after bone marrow punction.
- •refractory anaemia (RA): blood: ≤ 1% blasts, ≤ 1 x 109 monocytes; bone marrow: < 5% blasts, ringed sideroblasts ≤ 15% of the erythroid cells
- •refractory anaemia with ringed sideroblasts (RARS): blood: ≤ 1% blasts, ≤ 1 x 109 monocytes; bone marrow: < 5% blasts, ringed sideroblasts > 15% of the erythroid cells
- •refractory anaemia with excess blasts (RAEB): blood: < 5% blasts, ≤ 1 x 109 monocytes; bone marrow: blasts ≥ 5 -≤ 20%
- •chronic myelomonocytic leukaemia (CMML): blood: >1 x 109/l monocytes, <5% blasts; bone marrow: blasts < 20%, increase of the monocytic component
- •erythrocyte transfusion need
- •working knowledge of the national language
- •written consent for participating this study (informed consent)
排除标准
- •candidate for bone marrow- or organ transplantation
- •medication: growth factors (GM-CSF), or EPO
- •patients who will receive an intensive chemotherapeutic treatment with a cytopenia, expected longer than 2 weeks
- •refractory anaemia with excess blasts in transformation (RAEB-t): blood: ≥ 5% blasts or Auer rods; bone marrow: or blasts > 20 - < 30% or Auer rods
- •pregnancy at the moment of inclusion
- •patients with congenital severe haemolytic anaemia, like thalassemia or sickle cell anaemia
- •patients with AIDS or a severe congenital or acquired (e.g. iatrogenic) immunological disorder
- •severe active infections at the moment of inclusion
- •severe cardiac, pulmonal, neurological, metabolic or psychiatric disease at the moment of inclusion
结局指标
主要结局
fatigue
次要结局
- Health related Quality of Life, Blood usage and the costs, Haemoglobin increase after transfusion, Heart beat, blood pressure, temperature, platelet count, Development of RBC alloantibodies, Mortality
研究者
研究点 (2)
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