[Multicenter study of 2 urokinase protocols in severe pulmonary embolism. Research Group on Urokinase and Pulmonary Embolism].

The results of a multicentre trial (10 centres) of urokinase (UK) extracted from human urine in patients with recent massive pulmonary embolism (PE) are reported. The aim of this trial was to compare the efficacy of two protocols of UK therapy: low dose UK: 2 000 IU/kg/hour (UKl) associated with heparin, against high dose UK: 4 400 IU/kg/hour for 12 hours (UKh) followed by heparin. This randomised single blind trial included patients under 80 years of age. The clinical diagnosis of recent PE (less than 5 days) was confirmed by pulmonary angiography showing over 30% vascular obstruction (Miller index greater than 11). The efficacy of treatment was assessed by the degree of early revascularisation on pulmonary angiography 30 to 48 hours after the start of thrombolytic therapy, as analysed by 4 independent vascular radiologists. A total of 133 patients entered the trial between November 1978 and October 1981: 2 died before receiving treatment, 2 were excluded, 129 patients were retained (67 UKl and 62 UKh). The initial clinical, haemodynamic and angiographic parameters were comparable in the two groups: Miller index; 22.6 +/- 3.7 (UKl) and 22.6 +/- 3.4 (UKh), an average vascularisation defect of 66%. The efficacy of treatment was the same: 26% and 20% respectively. The incidence of haemorrhagic complications was the same in both groups: 24% and 29% respectively, but only 2% of patients had spontaneous severe bleeding.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes