NCT04688736招募中2 期
A Prospective, Randomized, Double-blind Controlled Trial of Chlorpheniramine Pretransfusion Medication for Allergic Transfusion Reactions
Institute of Hematology & Blood Diseases Hospital, China4 个研究点 分布在 1 个国家目标入组 6,642 人开始时间: 2021年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 6,642
- 试验地点
- 4
- 主要终点
- The rate of allergic-transfusion reactions
研究概览
简要总结
This is a prospective, randomized, double-blind controlled trial to evaluate the efficacy of placebo versus chlorpheniramine for the prevention of allergic transfusion reactions.
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
- Double (Participant, Investigator)
盲法说明
Neither patients nor medical staff, including physicians and nurses participating in this study, will know the group assignment after allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18~65 years old.
- •Subject is diagnosed with hematological disorder and requires blood product (i.e. suspended red blood cells, apheresis platelets, fresh frozen plasma) transfusions.
- •Subject can fully understand and voluntarily sign informed consent forms.
排除标准
- •Subject with a history of allergic diseases.
- •Subject experienced at least 1 moderate/severe or 2 mild allergic reactions in the past.
- •Subject received glucocorticoid or allergy drugs within 24 hours before blood transfusion.
- •Subject transfused with washed RBC.
- •Received allo-HSCT transplantation before.
- •Subject with heart failure.
- •Subject suffered from sequelae of cardiovascular or cerebrovascular diseases.
- •Pregnant or nursing women.
- •Inability to understand or to follow study procedures.
研究组 & 干预措施
Placebo
Experimental
Each recruited subject will oral 8mg placebo 20 minutes before blood transfusion.
干预措施: Placebo (Drug)
Chlorpheniramine
Active Comparator
Each recruited subject will oral 8mg chlorpheniramine 20 minutes before blood transfusion.
干预措施: Chlorpheniramine (Drug)
结局指标
主要结局
The rate of allergic-transfusion reactions
时间窗: within 4 hours from the start of the transfusion
次要结局
未报告次要终点
研究者
研究点 (4)
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