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

Overview

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

Full Title of Study: “A Prospective, Randomized, Double-blind Controlled Trial of Chlorpheniramine Pretransfusion Medication for Allergic Transfusion Reactions”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 31, 2025

Interventions

  • Drug: Placebo
    • The tablet resembles chlorpheniramine but has no therapeutic value.
  • Drug: Chlorpheniramine
    • An antihistamine that reduces the natural chemical histamine in the body.

Arms, Groups and Cohorts

  • Experimental: Placebo
    • Each recruited subject will oral 8mg placebo 20 minutes before blood transfusion.
  • Active Comparator: Chlorpheniramine
    • Each recruited subject will oral 8mg chlorpheniramine 20 minutes before blood transfusion.

Clinical Trial Outcome Measures

Primary Measures

  • The rate of allergic-transfusion reactions
    • Time Frame: within 4 hours from the start of the transfusion

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Institute of Hematology & Blood Diseases Hospital, China
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jun Shi, Director of Regenerative Medicine Clinic Center – Institute of Hematology & Blood Diseases Hospital, China
  • Overall Contact(s)
    • Jun Shi, PhD, (86)2223900913, shijun@ihcams.ac.cn

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