Journal Article
Randomized Controlled Trial
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The efficacy of aprotinin in arterial switch operations in infants.

BACKGROUND: In the present study we assessed whether aprotinin at a total dose (40,000 kallikrein inhibitor units (KIU)/kg) is effective in reducing postoperative blood loss and blood product requirement after arterial switch operations in infants.

METHODS: A prospective, double-blind, randomized study, evaluated 50 infants who underwent arterial switch operations for transposition of great arteries. Patients were randomized into a placebo group, 25 patients who received normal saline and a treatment group, 25 patients who received 20,000 KIU/kg of aprotinin after induction of anesthesia, followed by 20,000 KIU/kg of aprotinin added to pump prime. Postoperative blood loss through the thoracic chest tubes and blood product requirements (mL/kg/24 h) were measured for the first 24 h in the intensive care unit.

RESULTS: Postoperative blood loss in the first 24 h was significantly (P < 0.0001) higher in the placebo group (49.7 +/- 11.9 mL/kg/24 h) as compared to the aprotinin group (37.1 +/- 3.5 mL/kg/24 h). Requirements for fresh frozen plasma (mL/kg/24 h) and use of platelet concentrate transfusion (mL/kg/24 h) were significantly less in patients who received aprotinin (P < 0.0001), but did not reduce the proportion of patients transfused with blood products. The number of total donor exposures to all allogenic blood products was less in the aprotinin group [range (median) = 2-4 (3)] than the placebo group [range (median) = 7-14 (10)]. The re-exploration for excessive bleeding was significantly less with aprotinin group (16% vs 32%) (P = 0.01).

CONCLUSION: Our study concludes that aprotinin decreased the postoperative blood loss and requirement of transfusion of fresh frozen plasma and platelets (mL/kg/24 h) during the early postoperative period. Further, it reduced the number of donor exposures and re-exploration for excessive bleeding in the treatment population.

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