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NCT03957707: SOITBE

Sterotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation

Active, enrolled NA Last updated 2 October 2025
What this trial tests

NA trial testing stereotactic surgery plus thrombolysis in Basal Ganglia Haematoma in 380 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
1 January 2019
Primary endpoint
31 October 2025
31 October 2025

Quick facts

Lead sponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
PhaseNA
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment380
Start date1 January 2019
Primary completion31 October 2025
Estimated completion31 October 2025
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Who can join

Adults 18 to 70, any sex, with Basal Ganglia Haematoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Spontaneous cerebral hemorrhage is one of the main causes of death and disability all over the world, accounting for 20%-30% of all cerebrovascular diseases. Minimally invasive surgery of cerebral hemorrhage, especially puncture aspiration, can improve early and long-term neurological recovery in patients with cerebral hemorrhage. Until now, no standardized practice for minimally invasive surgery of spontaneous cerebral hemorrhage has been established. Hematoma puncture and drainage based on CT scans without precise localization and personalized approach design, which may lead to poor efficacy and high risk of complications. Our hospital has much experience in treating cerebral hemorrhage with stereotactic puncture and aspiration. So we conduct a prospective multicenter randomized controlled clinical trial to determine the therapeutic effects of puncture aspiration plus thrombolysis treatment for the perioperative and long-term recovery of patients with small to moderate hematoma in deep basal ganglia via computerized precision coordinates and personalized approach design.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Second Affiliated Hospital, School of Medicine, Zhejiang University trials

Trials by the same sponsor.

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Data sources for this page

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