Comparing Chlorpheniramine and placebo to prevent allergic reactions during blood transfusions
Official title: A Prospective, Randomized, Double-blind Controlled Trial of Chlorpheniramine Pretransfusion Medication for Allergic Transfusion Reactions
Run by Institute of Hematology & Blood Diseases Hospital, China · NCT04688736 · Data updated 2026-11-12
This study is testing if taking chlorpheniramine before a blood transfusion can help prevent allergic reactions in adults with blood disorders.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 6642 (estimated) |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Locations | 4 sites (Hefei, Anhui and 3 other locations) |
| Status | Recruiting |
| Started | January 1, 2021 |
| Main results expected | December 31, 2026 |
| Study ends | June 30, 2027 |
| Registry record updated | August 5, 2025 |
| Trial ID | NCT04688736 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 to 65 with hematological disorders requiring blood transfusions.
✕Probably not a fit
Patients with a history of allergic diseases or those who have experienced significant allergic reactions in the past may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial is a prospective, randomized, double-blind controlled trial designed to evaluate the effectiveness of chlorpheniramine compared to a placebo in preventing allergic transfusion reactions in patients with hematological disorders. Participants aged 18 to 65 who require blood product transfusions will be enrolled, and their reactions will be monitored to determine the efficacy of the intervention. The study aims to provide insights into whether premedication with chlorpheniramine can reduce the incidence of allergic reactions during transfusions.
Why it matters
Potential benefit: If successful, this study could significantly reduce the occurrence of allergic reactions during blood transfusions, improving patient safety and comfort.
How similar studies have gone: While similar studies have explored premedication for transfusion reactions, the specific efficacy of chlorpheniramine in this context is less established, making this approach somewhat novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Zhoukou Central Hospital
Zhoukou, Henan, China Recruiting -
The Second Affilated Hospital of Shandong First Medical University
Tai’an, Shandong, China Recruiting -
Regenerative Medicine Center
Tianjin, Tianjin Municipality, China Recruiting -
Anhui Provincial Hospital
Hefei, Anhui, China Not yet recruiting
Study contacts
- Study coordinator: Jun Shi, PhD
- Email: shijun@ihcams.ac.cn
- Phone: (86)2223900913
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.