NCT00261924已完成3 期
Clinical Trial to Evaluate the Therapeutic Efficacy and Safety of INTERCEPT Platelets Stored for up to Seven Days After Collection
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 1
- 主要终点
- 1 hour corrected count increment for platelets
研究概览
简要总结
Objective: To determine if platelets treated for pathogen inactivation and stored for 6 to 7 days are safe and effective compared to platelets collected by the same method, stored for the same amount of time and not treated for pathogen inactivation.
详细描述
Although the European Commission directive 2004/33/EC states that platelet preparations may be stored for 7 days in conjunction with detection or reduction of bacterial contamination, most blood centers store platelets for only 4 or 5 days. Extending the storage time could greatly improve platelet availability for patients while decreasing wastage of this limited resource.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 16 years old
- •Written informed consent
- •Thrombocytopenia, or expected to develop thrombocytopenia requiring platelet transfusion within 15 days of randomization
- •Undergoing one haematopoietic stem cell transplantation and/or admitted for treatment of acute or chronic leukaemia, lymphoma, multiple myeloma or myelodysplasia
排除标准
- •Refractoriness to platelet transfusion
- •Immune-mediated thrombocytopenia, thrombotic thrombocytopenic purpura, or hemolytic uremic syndrome
- •Use of IL-11 (Neumega®) or other investigational platelet growth factor
- •Disseminated intravascular coagulation (DIC)
- •Clinically or radiologically detectable splenomegaly
- •Previous participation in the study
结局指标
主要结局
1 hour corrected count increment for platelets
时间窗: One hour after platelet transfusion
1-h CCI
次要结局
- Transfusion related adverse events(24 hours after transfusion)
研究者
研究点 (1)
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