A single-centre double-blind trial of Trasylol therapy in primary acute pancreatitis

Abstract

One hundred and sixty-one consecutive patients with primary acute pancreatitis were admitted to a double-blind trial of intravenous Trasylol therapy as a supplement to a standard regimen of conservative management. The patients were subdivided into younger (less than 60 years) and older patients (aged 60 years and over), and subjects in each group were randomly allocated on a double-blind basis either to Trasylol therapy (starter 500 000 KIU and thereafter 200 000 q. i. d. for 5 days) or to placebo. There were 14 deaths (8.7 per cent), 7 in the Trasylol and 7 in the placebo group, and no significant difference was found in either the mortality or the major complications rate, either overall or within either age group. All 14 patients who died met the objective criteria for severe acute pancreatitis determined by the presence of at least three of a possible nine factors during the first 48 h of admission. Severe acute pancreatitis was present in 37 per cent of patients, who were evenly distributed between the Trasylol and placebo groups. Neither in those patients with severe nor those with less severe acute pancreatitis was there any significant difference between the two therapeutic regimens. Supplementary intravenous Trasylol therapy at this dosage confers no advantage over standard conservative treatment in the management of patients with primary acute pancreatitis.