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

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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called STAPLE for people with treatment of spontaneous intracerebral hemorrhage. The study is currently recruiting participants at 1 location. People eligible for this study include aged 40 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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