MCA Embolism Local Fibrinolytic Intervention Trial

UMIN ID: C000000139

Registered date:08/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Middle cerebral artery embolism
• Date of first enrollment: 2002/01/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

To receive local intraarterial Urokinase (infusion of 12,000U per 5min will be repeated until a total dose reaches 60,000U, two hours pass after starting infusion, or complete recanalization is achieved.)
No intraarterial intervention. Intravenous infusion of thrombolytic agents is prohibited in the both groups.

Outcome(s)

• Primary Outcome: Proportion of patients with slight or no neurologic disability at 90 days, as defined by a modified Rankin score of 2 or less. The ratio is compared between UK and conservative group.
• Secondary Outcome: Proportion of patients with slight or no neurologic disability at 90 days, as defined by a modified Rankin score of 1 or less. The ratio of good outcome is compared between UK and conservative group.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: NIHSS>22, rapid improvement, history of stroke within previous 90 days, seizures at onset, clinical presentation suggestive of subarachnoid hemorrhage, previous history or intracranial hemorrhage at any time, neoplasm, or subarachnoid hemorrhage, septic embolism, suspected lacunar stroke, surgery, biopsy of a parenchymal organ, trauma with internal injuries or lumbar puncture within 30 days, head trauma within 90 days, active or recent hemorrhage within 30 days, known hemorrhagic diathesis, known contrast sensitivity, sustained BP > 180/100, INR > 1.7, hemorrhage or major early infarction signs on CT scan.

Related Information

• Primary Sponsor: MELT Study Group
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare