A Phase 4 interventional study of Antihestamine and Placebo in Blood Transfusion Associated Adverse Reactions, sponsored by Kasr El Aini Hospital. Recruiting at 1 site in Egypt. Open to participants aged 1 Year to 7 Years. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by Kasr El Aini Hospital · Phase 4, Interventional, and Prevention
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.
56 studies on the registry are indexed under Transfusion Reaction; 12 are open to participants now.
This study's planned enrollment of 40 is below the median of 71 across 23 interventional studies indexed under Transfusion Reaction.
Browse Transfusion Reaction studies →Kasr El Aini Hospital is the lead sponsor of 287 studies on the registry; 34 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
chlorpheniramine 0.25 mg/Kg in 2 ml
Drug: Antihestamine
equal volume of normal saline
Drug: Placebo
chlorpheniramine 0.25 mg/Kg in 2 ml immediately after separation from CPB, before protamine administration
Also known as: chlorpheniramine
equal volume normal saline
hypotention episode incidance
Incidence of hypotension (20% MBP drop \< baseline)15 minutes post-CBP weaning
Time frame: 15 min,post cardiopulmonary bypass weaning
Plan to share: Undecided
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Studies of the drug tested here: Chlorpheniramine