Comparing Chlorpheniramine and placebo to prevent allergic reactions during blood transfusions
A Prospective, Randomized, Double-blind Controlled Trial of Chlorpheniramine Pretransfusion Medication for Allergic Transfusion Reactions
PHASE2 · Institute of Hematology & Blood Diseases Hospital, China · NCT04688736
This study is testing if taking chlorpheniramine before a blood transfusion can help prevent allergic reactions in adults with blood disorders.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 6642 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China (other) |
| Locations | 4 sites (Hefei, Anhui and 3 other locations) |
| Trial ID | NCT04688736 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 with hematological disorders requiring blood transfusions.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hefei, Anhui and 3 other locations
- Anhui Provincial Hospital — Hefei, Anhui, China (NOT_YET_RECRUITING)
- 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)
Study contacts
- Study coordinator: Jun Shi, PhD
- Email: shijun@ihcams.ac.cn
- Phone: (86)2223900913
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Allergic Transfusion Reaction, pretransfusion medication, Chlorpheniramine, blood transfusion, allergic transfusion reaction