Efficacy of Placebo Versus Chlorpheniramine for the Prevention of Allergic Transfusion Reactions. (NCT04688736) | Clinical Trial Compass
RecruitingPhase 2
Efficacy of Placebo Versus Chlorpheniramine for the Prevention of Allergic Transfusion Reactions.
China6,642 participantsStarted 2021-01-01
Plain-language summary
This is a prospective, randomized, double-blind controlled trial to evaluate the efficacy of placebo versus chlorpheniramine for the prevention of allergic transfusion reactions.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
What they're measuring
1
The rate of allergic-transfusion reactions
Timeframe: within 4 hours from the start of the transfusion
Trial details
NCT IDNCT04688736
SponsorInstitute of Hematology & Blood Diseases Hospital, China