Intra-arterial t-PA infusion during mechanical thrombectomy in acute ischemic stroke: a randomized trial.

Conditions

People with acute ischemic stroke (AIS) due to large vessel occlusion of the anterior circulation.

Brief summary

The proportion of patients achieving a mRS 0-1

Detailed description

The proportion of patients with dramatic clinical recovery (DCR). DCR will be defined as a decrease of ≥8 points from baseline NIHSS or a 24-hour NIHSS score ≤2., The proportion of patients achieving a mRS 0-2, The proportion of hemorrhagic complications. A non-contrast CT will be performed after 24 to 48 hours to evaluate the presence and degree of hemorrhagic transformation according to the ECASS-II criteria[3]., The proportion of symptomatic intracerebral hemorrhage (sICH), The proportion of death due to any cause, The proportion of patients who suffer a Safety Outcome. Safety outcome will be defined as the proportion of patients with the composite of: (i) symptomatic intracranial hemorrhage (ii) major bleeding due to access complications including groin hematoma, retroperitoneal hematoma (iii) contrast nephropathy., The proportion of patients discharged at home with or without services

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Interventions

DRUGActilyse

DRUGpolvo y disolvente para solución inyectable y para perfusión

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The proportion of patients achieving a mRS 0-1	—

Secondary

Measure	Time frame
The proportion of patients with dramatic clinical recovery (DCR). DCR will be defined as a decrease of ≥8 points from baseline NIHSS or a 24-hour NIHSS score ≤2., The proportion of patients achieving a mRS 0-2, The proportion of hemorrhagic complications. A non-contrast CT will be performed after 24 to 48 hours to evaluate the presence and degree of hemorrhagic transformation according to the ECASS-II criteria[3]., The proportion of symptomatic intracerebral hemorrhage (sICH), The proportion of death due to any cause, The proportion of patients who suffer a Safety Outcome. Safety outcome will be defined as the proportion of patients with the composite of: (i) symptomatic intracranial hemorrhage (ii) major bleeding due to access complications including groin hematoma, retroperitoneal hematoma (iii) contrast nephropathy., The proportion of patients discharged at home with or without services	—

Measure

Time frame

The proportion of patients with dramatic clinical recovery (DCR). DCR will be defined as a decrease of ≥8 points from baseline NIHSS or a 24-hour NIHSS score ≤2., The proportion of patients achieving a mRS 0-2, The proportion of hemorrhagic complications. A non-contrast CT will be performed after 24 to 48 hours to evaluate the presence and degree of hemorrhagic transformation according to the ECASS-II criteria[3]., The proportion of symptomatic intracerebral hemorrhage (sICH), The proportion of death due to any cause, The proportion of patients who suffer a Safety Outcome. Safety outcome will be defined as the proportion of patients with the composite of: (i) symptomatic intracranial hemorrhage (ii) major bleeding due to access complications including groin hematoma, retroperitoneal hematoma (iii) contrast nephropathy., The proportion of patients discharged at home with or without services

—

Countries

Spain

Outcome results

None listed