Stereotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation II — SOITBE II  

Basal Ganglia Hemorrhage Clinical Trial

Official title: Stereotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation II (SOITBE II)

Status Not yet recruiting

Clinical Trial Summary

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. The investigators' hospital has much experience in treating cerebral hemorrhage with stereotactic puncture and aspiration. So the investigators conduct a prospective multicenter randomized controlled clinical trial across the country to determine the therapeutic effects of puncture aspiration plus thrombolysis treatment for the perioperative and long-term recovery of patients with small hematoma in deep basal ganglia via computerized precision coordinates and personalized approach design.

Clinical Trial Description

1. Prospective enrollment of patients with small spontaneous basal ganglia hematoma according to the inclusion and exclusion criteria in 14 major neurosurgical centers across the country to establish a multi-center clinical database of spontaneous small basal ganglia hematoma with data maintenance and update.

2. Random allocation of the patients enrolled into control group (conservative treatment with conventional drugs) or intervention group (minimally invasive puncture aspiration plus rt-PA); long-term follow-up for 6 months to compare the recent and long-term mortality rate, disability rate and related complications of the two groups. ;

Related Conditions & MeSH terms

• Basal Ganglia Hemorrhage
• Ganglion Cysts
• Hemorrhage

• NCT number: NCT04172376
• Study type: Interventional
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2021
• Completion date: June 30, 2023