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โ† Trials
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Safety and Efficacy of Stereotactic Aspiration Plus Urokinase in Deep Intracerebral Hemorrhage Evacuation

RecruitingNAAges 40 Years - anyAllFirst Affiliated Hospital of Fujian Medical Univeโ€ฆ
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In plain words

What the trial is, and whether it could suit you

This is a nationwide, multicenter, open-label, randomized controlled trial of early minimally invasive treatment for deep-seated spontaneous cerebral hemorrhage (dICH). The study consists of 2 steps: the first step is to conduct a dose climbing test to determine the safety and optimal dose of urokinase intra-hematoma irrigation after stereotactic aspiration; the second step is to validate whether stereotactic aspiration plus urokinase irrigation (the optimal dose determined in step one) is superior to conservative treatment in improving long-term outcomes (1 year) in early (within 24h) dICH patients.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion criteria: 1. aged 40 years or older; 2. the duration from onset to the baseline computed tomography angiography (CTA) scan was between 6 to 24 hours; 3. patients with a spontaneous ICH in the deep brain parenchyma (โ‰ฅ1 cm from the cortical surface); with hematoma volume more than 25 ml (measured with the ABC/2 method); without hydrocephalus caused by intraventricular hemorrhage; without cerebral herniation and the benefit of surgical treatment was unknown; 4. The Glasgow Coma Scale (GCS) ranged from 9 to 15; 5. patients with motor deficits; 6. The modified Rankin Score (mRS) ranged from 0 to1 before onset. Exclusion Criteria: 1. ICH was caused by aneurysms, arteriovenous malformations, tumors, or trauma; 2. patients had a history of intracerebral hemorrhage or ischemic cerebral infarction; 3. patients had severe coagulation disorders with INR โ‰ฅ 1.5; 4. patients had severe underlying diseases, which may affect the outcomes; 5. pregnant and lactating patients; 6. patients refused to sign the informed consent and receive follow-up.
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What it tests

  • STAPLE
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Where

1 site
First Affiliated Hospital of Fujian Medical University
Fuzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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