A MULTICENTER TRIAL OF 6-AMINOCAPROIC ACID (AMICAR) IN THE PREVENTIONOF BLEEDING IN INFANTS ON ECMO

Background/Purpose: Intracranial hemorrhage (ICH), is a major source o f morbidity and the leading cause of death in neonates treated with ex tracorporeal membrane oxygenation [ECMO). Anecdotal reports have sugge sted that epsilon-aminocaproic acid (EACA) can decrease the risk of IC H. The purpose of this study was to evaluate, in a multiinstitutional, prospective, randomized, blinded fashion, the effect of EACA on the i ncidence of hemorrhagic complications in neonates receiving ECMO. Meth ods: All neonates (except congenital diaphragmatic hernia) who met cri teria for ECMO at three institutions were eligible for enrollment. EAC A (100 mg/kg) or placebo was given at the time of cannulation followed by 25 mg/kg/h for 72 hours. Bleeding complications, transfusion requi rements, and thrombotic complications were recorded. Post-ECMO imaging included head ultrasound scan computed tomography (CT) scan, and dupl ex ultrasound scan of the inferior vena cava and renal vessels. Result s: Twenty-nine neonates were enrolled (EACA, 13 and placebo, 16). Five (17.2%) patients had a significant (grade 3 or larger) ICH. There was no statistical difference in the incidence of significant ICH in pati ents who received EACA (23%] versus placebo (12.5%). Septic patients a ccounted for all of the ICH in the EACA group. Thrombotic complication s (aortic thrombus and SVC syndrome) developed in two patients from th e placebo group. There was no difference in thrombotic circuit complic ations between groups. Conclusions: Our results suggest that the use o f EACA in neonates receiving ECMO is safe but may not decrease the ove rall incidence of hemorrhagic complications. Copyright (C) 1998 by W.B . Saunders Company.