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2021年1月1日

适应症Allergic Transfusion Reaction

干预措施Placebo Chlorpheniramine

概览

阶段: 2 期
干预措施: Placebo
疾病 / 适应症: Allergic Transfusion Reaction
发起方: Institute of Hematology & Blood Diseases Hospital, China
入组人数: 6642
试验地点: 4
主要终点: The rate of allergic-transfusion reactions
状态: 招募中
最后更新: 9个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2021年1月1日

结束日期

2027年6月30日

最后更新

9个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Institute of Hematology & Blood Diseases Hospital, China

责任方

Sponsor

入排标准

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.