REVIEW OF EFFICACY PARAMETERS

Background. The deleterious effects of cardiopulmonary bypass are grea ter in pediatric patients than in adults. The use of aprotinin to mani pulate 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. R esults. Available studies have many deficiencies, often including lack of placebo control, nonhomogeneous populations and procedures, and ab sence 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 preser vation, particularly in neonates, to evaluate aprotinin's antiinflamma tory action, and to determine optimum dosages to achieve specific obje ctives. Aprotinin in pediatric cardiac surgery has been found to be as sociated with no adverse effects, to decrease fibrinolytic and probabl y platelet activation, and to offer important clinical benefits in spe cific groups of patients. (C) 1998 by The Society of Thoracic Surgeons .