Blood Transfusion Associated Adverse ReactionsPhase 4HTR - CPBNCT07536152
Antihistamine for Prevention of HTR After Blood Primed CPB
A Phase 4 study testing Antihestamine in people with Blood Transfusion Associated Adverse Reactions, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
This study will be a randomized, double-blinded, placebo-controlled study conducted at a university hospital. Forty children undergoing elective repair of a congenital heart defect will be included. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Blood Transfusion Associated Adverse Reactions
- What is being tested?
- Antihestamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2026to Dec 2026
- Phase
- Phase 4
- 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 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Acyanotic congenital heart disease.
- Age :1 -7 years.
- Genre: both.
Who cannot join
- Redo patient.
- History of allergy to antihistamines.
- Bleeding disorders with INR > 1.5 and/or platelets < 50,000.
- Emergency procedure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Misr Universty for Scince and Technology
Giza, October, 12582
Ahmed Mohamed Elhaddad, Assisstant Professor, 0201224042847, drblacksmith5@kasralainy.edu.eg
About this study
Official title: Prophylactic Antihistamine for Prevention of Hypotensive Transfusion Reaction After Blood Primed Cardiopulmonary Bypass in Pediatric Cardiac Surgery: a Randomized-controlled Study
This study will be a randomized, double-blinded, placebo-controlled study conducted at a university hospital. Forty children undergoing elective repair of a congenital heart defect will be included. The patients will be randomly allocated (20 patients per group) to receive a single intravenous dose of combined chlorpheniramine or normal saline immediately after separation from CPB, before protamine administration.
- Being tested
- Antihestamine, Placebo
- Keywords
- prevention of hypotensive transfusion reaction
- Medical subject headings
- Transfusion Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntihestamineDrug
Also called chlorpheniramine
chlorpheniramine 0.25 mg/Kg in 2 ml immediately after separation from CPB, before protamine administration
PlaceboDrug
equal volume normal saline
| Study group | Role | What they receive |
|---|---|---|
| Antihistamine | Active comparator | chlorpheniramine 0.25 mg/Kg in 2 ml Receives: Drug: Antihestamine |
| control | Placebo comparator | equal volume of normal saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypotention episode incidance
Incidence of hypotension (20% MBP drop < baseline)15 minutes post-CBP weaning
Measured: 15 min,post cardiopulmonary bypass weaning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 Mar 2026
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Transfusion Associated Adverse ReactionsStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Misr University for Science and Technology
- Responsible party
- Principal investigator, Ahmed Mohamed Mohamed Elhaddad, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07536152
- Sponsor's protocol ID
- 2026/0002
- Acronym
- HTR - CPB
- Status last verified
- Apr 2026
- First submitted
- 11 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Antihistamine for Prevention of Hypotensive Transfusion Reaction After Blood Primed Cardiopulmonary Bypass in Pediatric Cardiac Surgery: a Randomized-controlled Study
- ClinicalTrials.gov ID
- NCT07536152
- Acronym / sponsor ID
- HTR - CPB / 2026/0002
- Keywords
- prevention of hypotensive transfusion reaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Collaborators
- Misr University for Science and Technology
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Apr 2026 (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 study will be a randomized, double-blinded, placebo-controlled study conducted at a university hospital. Forty children undergoing elective repair of a congenital heart defect will be included. The patients will be randomly allocated (20 patients per group) to receive a single intravenous dose of combined chlorpheniramine or normal saline immediately after separation from CPB, before protamine administration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antihistamine | Active comparator | Drug: Antihestaminechlorpheniramine 0.25 mg/Kg in 2 ml |
| control | Placebo comparator | Drug: Placeboequal volume of normal saline |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Acyanotic congenital heart disease.
- Age :1 -7 years.
- Genre: both.
Key exclusion criteria (4 listed)
- Redo patient.
- History of allergy to antihistamines.
- Bleeding disorders with INR > 1.5 and/or platelets < 50,000.
- Emergency procedure.
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 |
|---|---|---|
| AntihestamineAlso: chlorpheniraminechlorpheniramine 0.25 mg/Kg in 2 ml immediately after separation from CPB, before protamine administration | Drug | Antihistamine |
| Placeboequal volume normal saline | Drug | control |
Primary outcome
hypotention episode incidance
Time frame: 15 min,post cardiopulmonary bypass weaning
Incidence of hypotension (20% MBP drop < baseline)15 minutes post-CBP weaning
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 21 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antihestamine in people with Blood Transfusion Associated Adverse Reactions, run by Kasr El Aini Hospital at 1 site in Egypt.
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 4 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 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hypotention episode incidance (time frame: 15 min,post cardiopulmonary bypass weaning). 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 21 Apr 2026.