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

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04688736
Enrollment
6642
Registered
2020-12-30
Start date
2021-01-01
Completion date
2027-06-30
Last updated
2025-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Transfusion Reaction

Keywords

pretransfusion medication, Chlorpheniramine, blood transfusion, allergic transfusion reaction

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.

Interventions

DRUGPlacebo

The tablet resembles chlorpheniramine but has no therapeutic value.

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

Sponsors

Institute of Hematology & Blood Diseases Hospital, China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Masking description

Neither patients nor medical staff, including physicians and nurses participating in this study, will know the group assignment after allocation.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
The rate of allergic-transfusion reactionswithin 4 hours from the start of the transfusion

Countries

China

Contacts

Primary ContactJun Shi, PhD
shijun@ihcams.ac.cn(86)2223900913
Backup ContactJingyu Zhao, MPH
zhaojingyu@ihcams.ac.cn(86)13752253515

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026