Review of Efficacy Parameters

Background. The deleterious effects of cardiopulmonary bypass are greater in pediatric patients than in adults. The use of aprotinin to manipulate hemostasis has become an important factor in attempts to reduce adverse consequences of these effects. Methods. This article reviews the literature on the use of aprotinin in pediatric cardiac surgery. Results. Available studies have many deficiencies, often including lack of placebo control, nonhomogeneous populations and procedures, and absence of information on aprotinin plasma concentrations. Comparison of trial results is further complicated by differences in dose regimens, heparin-protamine protocols, and priming. Conclusions. Further trials are required to adequately assess aprotinin effect on platelet preservation, particularly in neonates, to evaluate aprotinin’s antiinflammatory action, and to determine optimum dosages to achieve specific objectives. Aprotinin in pediatric cardiac surgery has been found to be associated with no adverse effects, to decrease fibrinolytic and probably platelet activation, and to offer important clinical benefits in specific groups of patients.