Placebo
DrugThe tablet resembles chlorpheniramine but has no therapeutic value.
Recruiting
NCT Number: NCT04688736
Efficacy of Placebo Versus Chlorpheniramine for the Prevention of Allergic Transfusion Reactions.
This is a prospective, randomized, double-blind controlled trial to evaluate the efficacy of placebo versus chlorpheniramine for the prevention of allergic transfusion reactions.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Anhui Provincial Hospital, Hefei, Anhui, China
Loading trial locations.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Chlorpheniramine
DrugAn antihistamine that reduces the natural chemical histamine in the body.
Primary outcomes
-
The rate of allergic-transfusion reactions
Time frame: within 4 hours from the start of the transfusion
Study contacts
Contact information is provided by the study sponsor or research team.
Jingyu Zhao, MPH
CONTACT
Jun Shi, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
Other
Registry information
Official study title
A Prospective, Randomized, Double-blind Controlled Trial of Chlorpheniramine Pretransfusion Medication for Allergic Transfusion Reactions
Important dates
- Study start
- 2021
- Primary completion
- 2026
- Study completion
- 2027
- First posted
- Dec 30, 2020
- Registry last updated
- Aug 5, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.