Status:
RECRUITING
Efficacy of Placebo Versus Chlorpheniramine for the Prevention of Allergic Transfusion Reactions.
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Allergic Transfusion Reaction
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
6642 Patients enrolled
Trial Details
Trial ID
NCT04688736
Start Date
January 1 2021
End Date
June 30 2027
Last Update
August 5 2025
Active Locations (4)
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1
Anhui Provincial Hospital
Hefei, Anhui, China
2
Zhoukou Central Hospital
Zhoukou, Henan, China
3
The Second Affilated Hospital of Shandong First Medical University
Tai’an, Shandong, China
4
Regenerative Medicine Center
Tianjin, Tianjin Municipality, China