A Prospective Non-interventional Study to Evaluate the Safety of Methylene Blue Plasma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 4
- 主要终点
- The incidence of transfusion reactions following administration of Methylene Blue Plasma based on the total number of transfusions administered
研究概览
简要总结
The objective of this non-interventional study is to gather data on adverse reactions occurring with Methylene Blue plasma administered in a routine clinical practice environment; to know more about their characteristics and behaviour and the possible factors that may influence their presentation and evolution.
详细描述
This is an open label, multi-centre, non-controlled, non-randomized, non-interventional study to evaluate the safety of Methylene Blue (MB) plasma. One centre per country will participate from United Kingdom, Belgium, Greece and Spain.
The haemovigilance Case Report Form (CRF) will be completed for all patients who receive a Methylene Blue plasma transfusion and experience an adverse reaction. The patients will be monitored for the occurrence of possible adverse reactions within 24 hours after start of the transfusion. If the patient experiences an adverse reaction, information about the adverse reaction will be documented. Serious adverse reactions will be collected within a 7-day period after the transfusion.
Each adverse reaction or serious adverse reaction will be followed up for 28 days after the occurrence of the reaction.
Each centre will provide the number of transfused Methylene Blue plasma units and the number of transfused Methylene Blue plasma patients every three months.
Information collected on the haemovigilance CRF will include:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients, who have received a transfusion with Methylene Blue plasma produced using the THERAFLEX MB-Plasma procedure from MacoPharma and experience an adverse reaction.
排除标准
- •Patients receiving transfusion with other plasma types during the same transfusion episode
结局指标
主要结局
The incidence of transfusion reactions following administration of Methylene Blue Plasma based on the total number of transfusions administered
时间窗: One year
次要结局
- The incidence of specific transfusion reactions following administration of Methylene Blue plasma(One year)