Efficacy of Placebo Versus Chlorpheniramine for the Prevention of Allergic Transfusion Reactions.

Institute of Hematology & Blood Diseases Hospital, China

Status and phase: Enrolling; Phase 2

Conditions: Allergic Transfusion Reaction

Treatments: Drug: Placebo; Drug: Chlorpheniramine

Study type: Interventional

Funder types: Other

Identifiers

NCT04688736

IIT2020032

Details and patient eligibility

About

This is a prospective, randomized, double-blind controlled trial to evaluate the efficacy of placebo versus chlorpheniramine for the prevention of allergic transfusion reactions.

Enrollment: 6,642 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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6,642 participants in 2 patient groups

Placebo

Experimental group

Description:

Each recruited subject will oral 8mg placebo 20 minutes before blood transfusion.

Treatment:

Drug: Placebo

Chlorpheniramine

Active Comparator group

Description:

Each recruited subject will oral 8mg chlorpheniramine 20 minutes before blood transfusion.

Treatment:

Drug: Chlorpheniramine