Blood Transfusion Associated Adverse Reactions
Conditions
Keywords
prevention of hypotensive transfusion reaction
Brief 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. 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.
Interventions
DRUGAntihestamine
chlorpheniramine 0.25 mg/Kg in 2 ml immediately after separation from CPB, before protamine administration
DRUGPlacebo
equal volume normal saline
Sponsors
Kasr El Aini Hospital
Misr University for Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
* Acyanotic congenital heart disease. * Age :1 -7 years. * Genre: both.
Exclusion criteria
* Redo patient. * History of allergy to antihistamines. * Bleeding disorders with INR \> 1.5 and/or platelets \< 50,000. * Emergency procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hypotention episode incidance | 15 min,post cardiopulmonary bypass weaning | Incidence of hypotension (20% MBP drop \< baseline)15 minutes post-CBP weaning |
Countries
Egypt
Outcome results
None listed