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Aprotinin in children undergoing correction of congenital heart defects. A double-blind pilot study
F Herynkopf1, F Lucchese, E Pereira
1Department of Cardiac Surgery, Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre, Brazil.
Insights
Aprotinin significantly reduced blood loss and transfusion needs in pediatric heart surgery patients. This antifibrinolytic agent proved safe and effective, improving outcomes and decreasing donor blood requirements.
Area of Science:
- Cardiovascular Surgery
- Pediatric Cardiac Surgery
- Pharmacology
Background:
- Congenital heart defects require surgical repair, often involving cardiopulmonary bypass.
- Minimizing blood loss and transfusion requirements is crucial in pediatric cardiac surgery.
Purpose of the Study:
- To evaluate the anti-hemorrhagic and blood-saving properties of aprotinin in children undergoing surgical repair of congenital heart defects.
- To assess the safety and efficacy of a specific aprotinin dosage regimen in this pediatric population.
Main Methods:
- A double-blind, randomized study involving 30 children undergoing surgical repair for congenital heart defects.
- Aprotinin (7 mg/kg) administered until the end of perfusion in the treatment group (n=14); placebo (saline) in the control group (n=16).
- Key outcome measures included intraoperative and postoperative blood loss, hemoglobin loss, donor blood requirements, and transfusion rates.
Main Results:
- Aprotinin treatment was associated with reduced intraoperative (12.6 vs 18.1 ml/kg) and 24-hour postoperative chest drainage (12.1 vs 17.7 ml/kg).
- Hemoglobin loss was halved in the aprotinin group (0.66 vs 1.21 gm/24h).
- Significantly fewer blood donors were needed (1.07 vs 2.75 per patient), and postoperative transfusions were unnecessary in 64.2% of aprotinin recipients versus 25% of placebo recipients (p=0.03).
- Aprotinin significantly increased diuresis during perfusion (4.3 vs 1.0 ml/kg, p=0.005).
Conclusions:
- Aprotinin demonstrates significant blood-saving properties in pediatric cardiac surgery.
- The drug appears safe and easy to administer in children, reducing the need for allogeneic blood transfusions.
- The evaluated dosage regimen warrants consideration for clinical application in this patient group.
Abstract:
Thirty children undergoing surgical repair for congenital heart defects were randomly selected for a double-blind study on the anti-hemorrhagic and blood-saving properties of aprotinin. The treatment group comprised 14 patients who received aprotinin 7 mg/kg of body weight until the end of perfusion. The placebo group (n = 16) received an infusion of the corresponding volumes of saline. Patients treated with aprotinin bled less during the operation (12.6 ml/kg versus 18.1 ml/kg, p = 0.25) and in the first 24 postoperative hours (chest drainage 12.1 ml/kg versus 17.7 ml/kg, p = 0.07). Hemoglobin loss into chest drainage was reduced in the treated group by half (0.66 versus 1.21 gm in 24 hours, p = 0.07). Fewer blood donors were needed during hospitalization by patients receiving aprotinin (1.07 versus 2.75 donors per patient, p = 0.04). Postoperative transfusion was unnecessary in 64.2% of patients receiving aprotinin compared with only 25% of the placebo group (p = 0.03). Aprotinin increased diuresis significantly during perfusion (4.3 ml/kg versus 1.0 ml/kg, p = 0.005). Other parameters are evaluated, and considerations are made regarding adequacy of the dosage regimen. The drug seems to be safe and easy to handle in children.