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临床试验/NCT00202371
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

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

发起方
Sanquin Research & Blood Bank Divisions
申办方类型
Other

研究点 (2)

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