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document
Comparison of intravenous and intra-arterial urokinase thrombolysis for acute ischaemic stroke . Intravenous fibrinolysis ( IVF ) with rt-PA ( alteplase ) provides significant benefits in acute ischaemic stroke when it is given within the first three hours following stroke onset . Intra-arterial fibrinolysis ( IAF ) with pro-urokinase in PROACT II study provides quite the same benefit in the first 6 hours . IVF and IAF have never been compared . To compare the efficacy and safety of IVF and IAF with urokinase given within the first 6 hours of acute ischaemic stroke . Patients fulfilling the selection criteria were randomly assigned to receive urokinase 900,000 units via intravenous or intra-arterial routes . This randomised monocentre study was done between December 1995 and August 1997 . The primary outcome was defined as the number of patients with a modified Rankin score of 2 or less . Secondary outcomes included mortality , frequency of symptomatic intracranial haemorrhage ( SIH ) , neurological and functional scores . Fourteen patients were given IVF and 13 IAF . The study was terminated by the National Health Authorities when 27 patients had been included because of the mortality rate . Seven patients ( 26 % ) died , 4 in the IV group ( oedematous infarct in 3 and recurrence in 1 ) , 3 in the IA group ( SIH in 2 , and oedematous infarct in 1 ) . Patients given IVF were treated significantly earlier ( 4:16 h vs 5:24 h ; p=.007 ) . Although IA patients showed greater and earlier improvement there was no significant difference in primary and secondary outcomes . Because of premature termination , the trial was too small to provide any reliable and conclusive results . Intra-arterial fibrinolysis began significantly later than IV fibrinolysis but it gave non-significantly better results in this prematurely terminated study .
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Intervention_Pharmacological
Intravenous fibrinolysis ( IVF ) with rt-PA ( alteplase )
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Intervention_Pharmacological
Intra-arterial fibrinolysis ( IAF ) with pro-urokinase
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Intervention_Pharmacological
IVF
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Intervention_Pharmacological
IAF
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Intervention_Pharmacological
IVF
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Intervention_Pharmacological
IAF
21131
Intervention_Pharmacological
urokinase
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Intervention_Pharmacological
IVF
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Intervention_Pharmacological
IAF
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Intervention_Pharmacological
IVF
21135
Outcome_Other
efficacy and safety
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Outcome_Other
number of patients with a modified Rankin score of 2 or less
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Outcome_Mortality
mortality
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Outcome_Physical
frequency of symptomatic intracranial haemorrhage ( SIH )
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Outcome_Other
neurological and functional scores
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Participant_Condition
acute ischaemic stroke
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Participant_Sample-size
Fourteen
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Participant_Sample-size
27