RecruitingPhase 2NCT04688736

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


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

6,642 participants

Start Date

Jan 1, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

  • \~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 Criteria9

  • 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.

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Interventions

DRUGPlacebo

The tablet resembles chlorpheniramine but has no therapeutic value.

DRUGChlorpheniramine

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


Locations(4)

Anhui Provincial Hospital

Hefei, Anhui, China

Zhoukou Central Hospital

Zhoukou, Henan, China

The Second Affilated Hospital of Shandong First Medical University

Tai’an, Shandong, China

Regenerative Medicine Center

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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NCT04688736