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

Phase 2

Recruiting

• Conditions: Allergic Transfusion Reaction
• Interventions: Drug: Placebo; Drug: Chlorpheniramine

• Registration Number: NCT04688736
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-25
• Study First Submitted QC: 2020-12-25
• Study First Posted: 2020-12-30
• Study Start: 2021-01-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-26
• Last Update Posted: 2023-11-28
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6642

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Each recruited subject will oral 8mg placebo 20 minutes before blood transfusion.
Chlorpheniramine	Chlorpheniramine	Each recruited subject will oral 8mg chlorpheniramine 20 minutes before blood transfusion.

Primary Outcome Measures

Name	Time	Method
The rate of allergic-transfusion reactions	within 4 hours from the start of the transfusion

Trial Locations

Locations (4)

Regenerative Medicine Center; 🇨🇳 Tianjin, Tianjin, China

Anhui Provincial Hospital; 🇨🇳 Hefei, Anhui, China

The Second Affilated Hospital of Shandong First Medical University; 🇨🇳 Tai'an, Shandong, China

Zhoukou Central Hospital; 🇨🇳 Zhoukou, Henan, China