Evaluation of the Safety and Performance of Platelet Transfusion Products Treated With MIRASOL® Pathogen Reduction Technology. A Study in Human Thrombocytopenic Subjects.
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 20
- 主要终点
- The platelet corrected count increment measured 1 hour post transfusion.
研究概览
简要总结
The primary objective of the study is to measure platelet corrected count increments and the incidence of serious adverse events (SAE). The primary endpoint is the platelet corrected count increment measured 1-hour post transfusion in response to the infusion of platelet concentrates treated with the Mirasol PRT System device (test product) versus untreated (reference product).
详细描述
The objective of the study is to determine if the MIRASOL Pathogen Reduction Technology (PRT) System for Platelets device performs safely and maintains adequate platelet performance in a clinical setting. This will be achieved by comparing the platelet corrected count increment measured 1 hour post transfusion and the incidence of serious adverse events in response to the infusion of platelet concentrates treated with the device (test product) versus untreated (reference product) in thrombocytopenic subjects requiring platelet transfusions. The performance, safety, and tolerability profile of the device will be further assessed by monitoring and comparing the incidence of discontinuations due to adverse events in relation to platelet transfusion up to 4 weeks after transfusion, including the incidence of transfusion associated infections, and the number and time between transfusions.
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
- None
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
- •Male or female of age of 16 years or older
- •Women of Child Bearing Potential not pregnant
- •Subject must have signed and dated the Informed Consent form
- •Hospitalized, thrombocytopenic subjects and expected to receive at least two platelets transfusion
排除标准
- •History of any hypersensitivity reaction to riboflavin or metabolites
- •History of refractoriness to platelet transfusions
- •Positive lymphocytotoxic antibody test
- •Active bleeding
- •Splenomegaly
- •Acute or chronic Disseminated Intravascular Coagulation
- •History or diagnosis of Immune/Idiopathic Thrombocytopenic Purpura, Thrombotic Thrombocytopenia Purpura, or Haemolytic Uremic Syndrome
- •History or diagnosis of an autoimmune disease affecting haemostasis
- •History of solid organ transplants
- •Evidence of occlusive venous disease
- •Clinical signs of infection at the time of inclusion
- •Pregnant or lactating females
- •Chronic alcohol misuse
- •Use of prohibited medications
结局指标
主要结局
The platelet corrected count increment measured 1 hour post transfusion.
次要结局
- The platelet corrected count increment measured 24 hours post-transfusion.
- The number of days between platelet transfusions during the period of the study.
- The number of platelet transfusions per subject.
- The number of platelets infused per subject.
- The number of platelets used.
- The frequency of refractoriness to platelet transfusion.
- In case of refractoriness, the evidence for neoantigen immunization against test product.
- The number of red blood cell transfusions during the study period.
- The incidence of serious adverse events in relation to platelet transfusions.
- The incidence of any adverse events in relation to platelet transfusions.
- The occurrence of bleeding episodes.