NCT04688736 Efficacy of Placebo Versus Chlorpheniramine for the Prevention of Allergic Transfusion Reactions.
| NCT ID | NCT04688736 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Allergic Transfusion Reaction |
| Study Type | INTERVENTIONAL |
| Enrollment | 6,642 participants |
| Start Date | 2021-01-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 6,642 participants in total. It began in 2021-01-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04688736 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Allergic Transfusion Reaction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04688736 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04688736 currently recruiting?
Yes, NCT04688736 is actively recruiting participants. Contact the research team at shijun@ihcams.ac.cn for enrollment information.
Where is the NCT04688736 trial being conducted?
This trial is being conducted at Hefei, China, Zhoukou, China, Tai’an, China, Tianjin, China.
Who is sponsoring the NCT04688736 clinical trial?
NCT04688736 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The trial plans to enroll 6,642 participants.