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Status:

RECRUITING

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

Lead Sponsor:

First Affiliated Hospital of Fujian Medical University

Collaborating Sponsors:

Department of Science and Technology of Fujian province

Longyan City First Hospital

Conditions:

Treatment of Spontaneous Intracerebral Hemorrhage

Eligibility:

All Genders

40+ years

Phase:

NA

Brief 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: ...

Detailed Description

Surgical options have been repeatedly evaluated in large multicenter randomized controlled trials that unfortunately have not demonstrated improved outcomes. Recently, MISTIE III study concluded that ...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • 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 Criteria:
  • 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.

Exclusion

    Key Trial Info

    Start Date :

    January 31 2021

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    September 30 2025

    Estimated Enrollment :

    400 Patients enrolled

    Trial Details

    Trial ID

    NCT04686877

    Start Date

    January 31 2021

    End Date

    September 30 2025

    Last Update

    February 12 2025

    Active Locations (1)

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    First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, China