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

November 26, 2023 updated by: Jun Shi, Institute of Hematology & Blood Diseases Hospital, China

A Prospective, Randomized, Double-blind Controlled Trial of Chlorpheniramine Pretransfusion Medication for Allergic Transfusion Reactions

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

6642

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Not yet recruiting
        • Anhui Provincial Hospital
        • Contact:
    • Henan
      • Zhoukou, Henan, China
        • Recruiting
        • Zhoukou Central Hospital
        • Contact:
    • Shandong
      • Tai'an, Shandong, China
        • Recruiting
        • The Second Affilated Hospital of Shandong First Medical University
        • Contact:
    • Tianjin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Placebo
Each recruited subject will oral 8mg placebo 20 minutes before blood transfusion.
Drug: Placebo
The tablet resembles chlorpheniramine but has no therapeutic value.
Active Comparator: Chlorpheniramine
Each recruited subject will oral 8mg chlorpheniramine 20 minutes before blood transfusion.
Drug: Chlorpheniramine
An antihistamine that reduces the natural chemical histamine in the body.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

December 25, 2020

First Submitted That Met QC Criteria

December 25, 2020

First Posted (Actual)

December 30, 2020

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 26, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IHBDH-CTA202101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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