Horwitz J R, Cofer B R, Warner B W, Cheu H W, Lally K P
University of Texas-Houston Medical School and Hermann Children's Hospital, USA.
J Pediatr Surg. 1998 Nov;33(11):1610-3. doi: 10.1016/s0022-3468(98)90591-7.
BACKGROUND/PURPOSE: Intracranial hemorrhage (ICH), is a major source of morbidity and the leading cause of death in neonates treated with extracorporeal membrane oxygenation (ECMO). Anecdotal reports have suggested that epsilon-aminocaproic acid (EACA) can decrease the risk of ICH. The purpose of this study was to evaluate, in a multiinstitutional, prospective, randomized, blinded fashion, the effect of EACA on the incidence of hemorrhagic complications in neonates receiving ECMO.
All neonates (except congenital diaphragmatic hernia) who met criteria for ECMO at three institutions were eligible for enrollment. EACA (100 mg/kg) or placebo was given at the time of cannulation followed by 25 mg/kg/h for 72 hours. Bleeding complications, transfusion requirements, and thrombotic complications were recorded. Post-ECMO imaging included head ultrasound scan computed tomography (CT) scan, and duplex ultrasound scan of the inferior vena cava and renal vessels.
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 patients who received EACA (23%) versus placebo (12.5%). Septic patients accounted for all of the ICH in the EACA group. Thrombotic complications (aortic thrombus and SVC syndrome) developed in two patients from the placebo group. There was no difference in thrombotic circuit complications between groups.
Our results suggest that the use of EACA in neonates receiving ECMO is safe but may not decrease the overall incidence of hemorrhagic complications.
背景/目的：颅内出血（ICH）是接受体外膜肺氧合（ECMO）治疗的新生儿发病的主要原因及死亡的首要原因。有报道称，ε-氨基己酸（EACA）可降低ICH风险。本研究旨在以多机构、前瞻性、随机、盲法的方式评估EACA对接受ECMO治疗的新生儿出血并发症发生率的影响。
在三家机构中，所有符合ECMO标准的新生儿（先天性膈疝除外）均符合入组条件。插管时给予EACA（100mg/kg）或安慰剂，随后以25mg/kg/h的速度持续给药72小时。记录出血并发症、输血需求及血栓形成并发症。ECMO治疗后成像包括头部超声扫描、计算机断层扫描（CT）以及下腔静脉和肾血管的双功超声扫描。
共纳入29例新生儿（EACA组13例，安慰剂组16例）。5例（17.2%）患者发生严重（3级及以上）ICH。接受EACA治疗的患者（23%）与接受安慰剂治疗的患者（12.5%）相比，严重ICH的发生率无统计学差异。EACA组所有的ICH均发生在脓毒症患者中。安慰剂组有2例患者发生血栓形成并发症（主动脉血栓和上腔静脉综合征）。两组间血栓形成回路并发症无差异。
我们的结果表明，在接受ECMO治疗的新生儿中使用EACA是安全的，但可能不会降低出血并发症的总体发生率。
