The Bayer 022 Compassionate-Use Pediatric Study

Background. As part of a compassionate-use study, a placebo-controlled study was undertaken to assess the efficacy of aprotinin in patients undergoing any procedure associated with cardiopulmonary bypass and at increased risk of perioperative bleeding. This article reviews results in 116 patients 16 years of age or less. Methods. Patients were randomly assigned to four treatment groups: high dose, low dose, pump prime only, and placebo. Efficacy was measured by four parameters: requirement for units of donor blood, requirement for units of donor blood and blood product, thoracic drainage volumes, and rates of reoperation required primarily because of diffuse bleeding. Results were separately analyzed in all patients, patients undergoing primary procedures, patients undergoing repeat procedures, neonates and infants 1 year of age or less, and patients older than 1 year of age. Results. There was a trend toward reduced blood and blood product requirements with aprotinin use, least evident in neonates and infants and particularly evident in patients undergoing repeat procedures. Aprotinin did not reduce drainage volumes in this pediatric population. Conclusions. There is a trend toward benefit with aprotinin use in a pediatric population, as measured by requirement for blood and blood product, in patients who are more than 1 year of age and in patients undergoing a repeat operation rather than a primary sternotomy operation.