Allergic Transfusion ReactionPhase 2NCT04688736
Efficacy of Placebo Versus Chlorpheniramine for the Prevention of Allergic Transfusion Reactions.
A Phase 2 study testing Chlorpheniramine in people with Allergic Transfusion Reaction, run by Institute of Hematology & Blood Diseases Hospital, China at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Transfusion Reaction
- What is being tested?
- Chlorpheniramine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6,642 participants
- Where
- 4 sitesChina
- Study dates
- 1 Jan 2021to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Subject suffered from sequelae of cardiovascular or cerebrovascular diseases.
- Pregnant or nursing women.
- Inability to understand or to follow study procedures.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Not yet recruiting
Anhui Provincial Hospital
Hefei, Anhui
Xiaoyu Zhu, PhD, xiaoyuz@ustc.edu.cn
- Recruiting
The Second Affilated Hospital of Shandong First Medical University
Tai’an, Shandong
Hong Zhang, 18505386878, tyfyzhh@163.com
- Recruiting
Regenerative Medicine Center
Tianjin, Tianjin Municipality
Jun Shi, PhD, (86)2223900913, shijun@ihcams.ac.cn
Zhexiang Kuang, MN, kuangzhexiang@ihcams.ac.cn
- Recruiting
Zhoukou Central Hospital
Zhoukou, Henan
Qian Liang, PhD, 15703815972, lqw141230@163.com
About this study
Official title: A Prospective, Randomized, Double-blind Controlled Trial of Chlorpheniramine Pretransfusion Medication for 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.
- Conditions
- Allergic Transfusion Reaction
- Being tested
- Placebo, Chlorpheniramine
- Keywords
- pretransfusion medication, Chlorpheniramine, blood transfusion, allergic transfusion reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
The tablet resembles chlorpheniramine but has no therapeutic value.
ChlorpheniramineDrug
An antihistamine that reduces the natural chemical histamine in the body.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | Each recruited subject will oral 8mg placebo 20 minutes before blood transfusion. Receives: Drug: Placebo |
| Chlorpheniramine | Active comparator | Each recruited subject will oral 8mg chlorpheniramine 20 minutes before blood transfusion. Receives: Drug: Chlorpheniramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of allergic-transfusion reactions
Measured: within 4 hours from the start of the transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start1 Jan 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Transfusion ReactionStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6,642 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688736
- Sponsor's protocol ID
- IIT2020032
- Status last verified
- Mar 2025
- First submitted
- 25 Dec 2020
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind Controlled Trial of Chlorpheniramine Pretransfusion Medication for Allergic Transfusion Reactions
- ClinicalTrials.gov ID
- NCT04688736
- Acronym / sponsor ID
- IIT2020032
- Conditions
- Allergic Transfusion Reaction
- Keywords
- pretransfusion medication, Chlorpheniramine, blood transfusion, allergic transfusion reaction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,642 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized, double-blind controlled trial to evaluate the efficacy of placebo versus chlorpheniramine for the prevention of allergic transfusion reactions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Drug: PlaceboEach recruited subject will oral 8mg placebo 20 minutes before blood transfusion. |
| Chlorpheniramine | Active comparator | Drug: ChlorpheniramineEach recruited subject will oral 8mg chlorpheniramine 20 minutes before blood transfusion. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboThe tablet resembles chlorpheniramine but has no therapeutic value. | Drug | Placebo |
| ChlorpheniramineAn antihistamine that reduces the natural chemical histamine in the body. | Drug | Chlorpheniramine |
Primary outcome
The rate of allergic-transfusion reactions
Time frame: within 4 hours from the start of the transfusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chlorpheniramine in people with Allergic Transfusion Reaction, run by Institute of Hematology & Blood Diseases Hospital, China at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Shi, PhD ((86)2223900913, shijun@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of allergic-transfusion reactions (time frame: within 4 hours from the start of the transfusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.