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Recruiting NCT04688736

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

Phase II Interventional Allergic Transfusion Reaction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Placebo, Chlorpheniramine.
Who it may be relevant to
Registry conditions: Allergic Transfusion Reaction. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Primary outcome measures

  • The rate of allergic-transfusion reactions [Time frame: within 4 hours from the start of the transfusion]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

China · 4 centers
  • Anhui Provincial Hospital — Hefei
  • Zhoukou Central Hospital — Zhoukou
  • The Second Affilated Hospital of Shandong First Medical University — Tai’an
  • Regenerative Medicine Center — Tianjin

Identifiers

NCT: NCT04688736 · IIT2020032

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗