A multicenter trial of 6-aminocaproic acid (Amicar) in the prevention of bleeding in infants on ECMO
Journal of Pediatric Surgery. 1998;33((11):):1610-3.
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. METHODS 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. RESULTS 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. CONCLUSIONS Our results suggest that the use of EACA in neonates receiving ECMO is safe but may not decrease the overall incidence of hemorrhagic complications.
Effect of aprotinin in adult respiratory distress syndrome
Anaesthesia & Intensive Care. 1986;14((4):):390-9.
The possible beneficial effect of aprotinin, a broad protease inhibitor, on the incidence and outcome of ARDS was examined in two complementary studies. In the first study, the effect of aprotinin was assessed in 147 patients admitted with multiple trauma or shock. In the 57 patients who developed ARDS, mortality was significantly less in those who had previously received aprotinin (8/20, 40%) than in those who had not (26/37, 70%). Although both treatment groups were well matched, this was a retrospective study and a second prospective, randomised, controlled study was therefore carried out. In 78 patients at risk of ARDS, there was no significant difference between treated and control patients in the incidence, duration or severity of ARDS, or in mortality or other major complications. It is concluded that aprotinin is not effective in improving any aspect of ARDS or its outcome in seriously ill patients.
Tranexamic acid in the prevention of periventricular haemorrhage
Archives of Disease in Childhood. 1984;59((8):):719-21.
Increased fibrinolytic activity in the ganglionic eminence of the preterm human brain has been proposed as a factor in the aetiology of periventricular haemorrhage. The effect of tranexamic acid in preventing periventricular haemorrhage was evaluated in 100 infants in a double blind, randomised controlled trial. Haemorrhages developed in 22 infants who received tranexamic acid and in 20 of those who received placebo. A significant reduction in fibrin degradation products in treated infants was seen. Our study suggests that excessive fibrinolytic activity is not an important factor in the aetiology of periventricular haemorrhage and that treatment with tranexamic acid will not prevent its occurrence.