NCT04688736
Recruiting
Phase 2
A Prospective, Randomized, Double-blind Controlled Trial of Chlorpheniramine Pretransfusion Medication for Allergic Transfusion Reactions
Institute of Hematology & Blood Diseases Hospital, China4 sites in 1 country6,642 target enrollmentJanuary 1, 2021
ConditionsAllergic Transfusion Reaction
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Allergic Transfusion Reaction
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Enrollment
- 6642
- Locations
- 4
- Primary Endpoint
- The rate of allergic-transfusion reactions
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Placebo
Each recruited subject will oral 8mg placebo 20 minutes before blood transfusion.
Intervention: Placebo
Chlorpheniramine
Each recruited subject will oral 8mg chlorpheniramine 20 minutes before blood transfusion.
Intervention: Chlorpheniramine
Outcomes
Primary Outcomes
The rate of allergic-transfusion reactions
Time Frame: within 4 hours from the start of the transfusion
Study Sites (4)
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