EUCTR2015-001035-20-DE进行中（未招募）1 期
Phase III, randomized, double-blind, multicentre clinical trial on clinical efficacy and safety of platelet concentrates treated with the THERAFLEX UV-Platelets procedure in comparison to conventional platelet components (Capture). - Capture trial
DRK-Blutspendedienst NSTOB0 个研究点目标入组 166 人开始时间: 2015年7月27日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 166
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- Haemato-oncological patients with thrombocytopenia or expected to become
- •thrombocytopenic;
- •- Expected to receive = 1PLT transfusions during their hospital stay;
- •- Age = 18 years;
- •- Written Informed Consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 116
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •- Known immunological refractoriness to PLT transfusions, i.e. HLA and/or HPA
- •alloimmunization (documented in the patient’s medical record);
- •- History or diagnosis of an autoimmune disease affecting haemostasis;
- •- Acute or chronic Disseminated Intravascular Coagulation (DIC);
- •- History or diagnosis of Thrombotic Thrombocytopenic Purpura or Haemolytic Uremic Syndrome;
- •- Severe uncontrolled infection;
- •- Positive serum or urine pregnancy test;
- •- Lactation;
- •- Simultaneous participation in another interventional Trial;
- •- Previous inclusion in this trial;
- •- Acute promyelocytic leukemia (AML, FAB subtype M3)
- •- Active bleeding at time of enrolment requiring one or more RBC transfusions and/or therapeutic platelet transfusions;
- •- Splenomegaly defined as a palpable spleen felt more than 4 cm below costal margin;
- •- History of severe anaphylactic transfusion criteria;
- •- Legal incapacity or other circumstances preventing the patient from understanding the nature, meaning and implications of the clinical Trial.
研究者
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