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RecruitingNot ApplicableNCT04686877

Safety and Efficacy of Stereotactic Aspiration Plus Urokinase in Deep Intracerebral Hemorrhage Evacuation

Safety and Efficacy of Stereotactic Aspiration Plus Urokinase in Deep Intracerebral Hemorrhage Evacuation: a Multicentral Randomized, Controlled, Open-label, Trial

Sponsor

First Affiliated Hospital of Fujian Medical University

Enrollment

400 participants

Start Date

Jan 31, 2021

Study Type

INTERVENTIONAL

Conditions

Treatment of Spontaneous Intracerebral Hemorrhage

Summary

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.

Eligibility

Min Age: 40 Years

Inclusion Criteria6

  • aged 40 years or older;
  • the duration from onset to the baseline computed tomography angiography (CTA) scan was between 6 to 24 hours;
  • patients with a spontaneous ICH in the deep brain parenchyma (≥1 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;
  • The Glasgow Coma Scale (GCS) ranged from 9 to 15;
  • patients with motor deficits;
  • The modified Rankin Score (mRS) ranged from 0 to1 before onset.

Exclusion Criteria6

  • ICH was caused by aneurysms, arteriovenous malformations, tumors, or trauma;
  • patients had a history of intracerebral hemorrhage or ischemic cerebral infarction;
  • patients had severe coagulation disorders with INR ≥ 1.5;
  • patients had severe underlying diseases, which may affect the outcomes;
  • pregnant and lactating patients;
  • patients refused to sign the informed consent and receive follow-up.

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Interventions

PROCEDURESTAPLE

Stereotactic aspiration plus urokinase clot irrigation

Locations(1)

First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

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NCT04686877