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

NCT04688736 | Recruiting Phase 2

• 1 other identifier: IIT2020032
• Study Type: interventional
• Target: 6,642
• Locations: 1 country
• Sites: 4

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.

Conditions

Allergic Transfusion Reaction

Keywords

pretransfusion medication; Chlorpheniramine; blood transfusion; allergic transfusion reaction

Outcome Measures

Primary Outcomes (1)

• The rate of allergic-transfusion reactions

  within 4 hours from the start of the transfusion

Study Arms (2)

Placebo

EXPERIMENTAL

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

Drug: Placebo

Chlorpheniramine

ACTIVE COMPARATOR

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

Drug: Chlorpheniramine

Interventions

Placebo DRUG

The tablet resembles chlorpheniramine but has no therapeutic value.

Placebo

Chlorpheniramine DRUG

An antihistamine that reduces the natural chemical histamine in the body.

Chlorpheniramine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (4)

Anhui Provincial Hospital

Hefei, Anhui, China

NOT YET RECRUITING

Zhoukou Central Hospital

Zhoukou, Henan, China

RECRUITING

The Second Affilated Hospital of Shandong First Medical University

Tai’an, Shandong, China

RECRUITING

Regenerative Medicine Center

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Interventions

Chlorpheniramine

Intervention Hierarchy (Ancestors)

Pheniramine; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Jun Shi, PhD

CONTACT

(86)2223900913; shijun@ihcams.ac.cn

Jingyu Zhao, MPH

CONTACT

(86)13752253515; zhaojingyu@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Neither patients nor medical staff, including physicians and nurses participating in this study, will know the group assignment after allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2020
• First Posted: December 30, 2020
• Study Start: January 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)