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J. Thorac. Cardiovasc. Surg. · Sep 1994
Randomized Controlled Trial Clinical TrialAprotinin in children undergoing correction of congenital heart defects. A double-blind pilot study.
- F Herynkopf, F Lucchese, E Pereira, R Kalil, P Prates, and I A Nesralla.
- Department of Cardiac Surgery, Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre, Brazil.
- J. Thorac. Cardiovasc. Surg. 1994 Sep 1;108(3):517-21.
AbstractThirty 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.
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