Stereotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation II

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.

Conditions

• Basal Ganglia Hemorrhage

Interventions

PROCEDURE

Minimally invasive puncture aspiration plus rt-PA

Stereotactic puncture aspiration to evacuate basal ganglion hematoma with use of thrombolytic agent

DRUG

Conservative medical treatment

Drugs for symptomatic treatment such as hemostasis and nerve nourishing.

Sponsors & Collaborators

• Huashan Hospital

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• Southern Medical University, China

  collaborator OTHER

• China-Japan Friendship Hospital

  collaborator OTHER

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• Second Affiliated Hospital of Xi'an Jiaotong University

  collaborator OTHER

• The Affiliated Hospital Of Southwest Medical University

  collaborator OTHER

• Tibet Autonomous Region People's Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• First Affiliated Hospital of Xinjiang Medical University

  collaborator OTHER

• The Affiliated Hospital of Inner Mongolia Medical University

  collaborator OTHER

• General Hospital of Ningxia Medical University

  collaborator OTHER

• Central South University

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-01

Primary Completion

2022-12-31

Completion

2023-06-30