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

Allergic Transfusion Reaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04688736
• Other study ID #: IHBDH-CTA202101
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2021
• Est. completion date: June 30, 2026

Study information

• Verified date: November 2023
• Source: Institute of Hematology & Blood Diseases Hospital, China
• Contact: Jun Shi, PhD
• Phone: (86)2223900913
• Email: shijun[@]ihcams.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6642
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Transfusion Reaction
• Transfusion Reaction

Intervention

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

Locations

Country	Name	City	State
China	Anhui Provincial Hospital	Hefei	Anhui
China	The Second Affilated Hospital of Shandong First Medical University	Tai'an	Shandong
China	Regenerative Medicine Center	Tianjin	Tianjin
China	Zhoukou Central Hospital	Zhoukou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of allergic-transfusion reactions		within 4 hours from the start of the transfusion