NL-OMON43833已完成3 期
Clinical effectiveness of standard versus pathogen-reduced buffy coat-derived platelet concentrates in plasma in hemato-oncological patients;Pathogen Reduction Evaluation & Predictive Analytical Rating Score (The PREPAReS Study) - The PREPAReS Study
Sanquin bloedvoorziening0 个研究点目标入组 400 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Age * 18 years.
- •* Expected * 2 platelet transfusion requirements.
- •* Having a hemato-oncological disease
排除标准
- •* Micro-angiopathic thrombocytopenia (TTP, HUS) and ITP
- •* Bleeding > grade 2 at randomization ( after treatment, the patient can be randomized in the study after 2 or more weeks after the last transfusion that was used to stop the bleeding)
- •* Known immunological refractoriness to platelet transfusions.
- •* HLA- and/or HPA-allo immunization and/or clinical relevant auto-antibodies.
- •* Indications to use hyper-concentrated (plasma-reduced) platelet concentrates, i.e. patients with known severe allergic reactions and documented transfusion-associated circulatory overload (TACO)
- •* Pregnancy (or lactating)
- •* Prior treatment with pathogen-reduced blood products
- •* Known allergy to riboflavin or its photoactive products
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