The UKEP study: multicentre clinical trial on two local regimens of urokinase in massive pulmonary embolism. The UKEP Study Research Group.
A multicentre trial (10 centres) of urokinase (UK) was performed in patients with acute severe pulmonary embolism (PE). The aim of this trial was, to compare the efficacy of two doses of UK administered via a catheter in the pulmonary artery: 2000 IU kg-1 h-1 for 24 hours (UK 2000) in conjunction with heparin versus 4400 IU kg-1 h-1 UK alone for 12 hours (UK 4400) followed by heparin. PE was less than 5 days old and the clinical diagnosis was confirmed by pulmonary angiograms demonstrating a vascular obstruction of more than 30% (Miller's index greater than 11). The efficacy of treatment was evaluated by the degree of early revascularization (pulmonary angiograms were performed 30 to 48 hours after initiation of thrombolytic treatment and analysed blindly by four independent vascular radiologists). 133 patients were included in this trial: two patients died before treatment and two were excluded retrospectively, leaving 129 patients for final analysis (67: UK 2000 + heparin; 62: UK 4400). The two groups had similar pretreatment clinical, haemodynamic and angiographic characteristics: the Miller angiographic index of severity averaged 22.6 +/- 3.7 for patients in the UK 2000 group, and 22.6 +/- 3.4 for patients in the UK 4400 group (average filling defect of 66% on pulmonary angiograms). There was a similar and significant degree of resolution in the two groups: 26% and 20%, respectively. Minor and major bleeding problems were observed with equal frequency in the two groups (24% and 29%, respectively). These bleeding complications were severe in only 4.5% and 3%, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)
D000368:Aged; D002986:Clinical Trials as Topic; D004359:Drug Therapy, Combination; D005260:Female; D005340:Fibrinogen / Q000032:analysis; D006471:Gastrointestinal Hemorrhage / Q000209:etiology; D006439:Hemodynamics; D006493:Heparin / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D011651:Pulmonary Artery / Q000000981:diagnostic imaging; D011655:Pulmonary Embolism / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D011859:Radiography; D011897:Random Allocation; D014568:Urokinase-Type Plasminogen Activator / Q000008:administration & dosage* / Q000009:adverse effects
D005340:Fibrinogen; D006493:Heparin; D014568:Urokinase-Type Plasminogen Activator