Minimally invasive treatment for deep brain bleeding
Official title: Safety and Efficacy of Stereotactic Aspiration Plus Urokinase in Deep Intracerebral Hemorrhage Evacuation: a Multicentral Randomized, Controlled, Open-label, Trial
Run by First Affiliated Hospital of Fujian Medical University · NCT04686877 · Data updated 2026-11-12
This study is testing a new, less invasive treatment for deep brain bleeding to see if it helps patients recover better than standard care when given soon after symptoms start.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | First Affiliated Hospital of Fujian Medical University Academic / other |
| Locations | 1 site (Fuzhou, Fujian) |
| Status | Recruiting |
| Started | January 31, 2021 |
| Main results expected | August 31, 2025 |
| Study ends | September 30, 2025 |
| Registry record updated | February 12, 2025 |
| Trial ID | NCT04686877 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 40 and older with specific criteria related to the timing and severity of their intracerebral hemorrhage.
✕Probably not a fit
Patients with hemorrhages caused by aneurysms, tumors, or those with severe coagulation disorders may not benefit from this treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This nationwide, multicenter trial evaluates the safety and efficacy of a minimally invasive approach combining stereotactic aspiration and urokinase irrigation for treating deep-seated spontaneous intracerebral hemorrhage (dICH). The study consists of two phases: the first phase determines the optimal and safe dose of urokinase through a dose climbing test, while the second phase compares the outcomes of this combined treatment against conservative management in patients treated within 24 hours of symptom onset. The goal is to improve long-term recovery outcomes for patients suffering from dICH.
Why it matters
Potential benefit: If successful, this approach could significantly enhance recovery outcomes for patients with deep brain bleeding.
How similar studies have gone: While previous studies have explored similar minimally invasive techniques, this specific approach is novel and aims to address limitations found in earlier research.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 (≥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; 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 ≥ 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.
Where it's running
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First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China Recruiting
Study contacts
- Study coordinator: Lin Fuxin, PHD,MD
- Email: lfxstuy@126.com
- Phone: +86 13552358381
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.