Safety and Efficacy of Stereotactic Aspiration Plus Urokinase in Deep Intracerebral Hemorrhage Evacuation

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.

Conditions

• Treatment of Spontaneous Intracerebral Hemorrhage

Interventions

PROCEDURE

STAPLE

Stereotactic aspiration plus urokinase clot irrigation

Sponsors & Collaborators

• Department of Science and Technology of Fujian province

  collaborator UNKNOWN

• Longyan City First Hospital

  collaborator OTHER

• Fifth Affiliated Hospital of Zhengzhou University

  collaborator UNKNOWN

• Shanxi Provincial People's Hospital

  collaborator OTHER_GOV

• Tangshan Gongren Hospital

  collaborator OTHER

• Lanzhou University Second Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University (Qingdao)

  collaborator OTHER

• The Second Hospital of Shandong University

  collaborator OTHER

• Shishi General Hospital

  collaborator UNKNOWN

• Wuping County Hospital

  collaborator UNKNOWN

• Fuqing Municipal Hospital

  collaborator UNKNOWN

• Qingyuan People's Hospital

  collaborator OTHER

• Jinjiang Municipal Hospital

  collaborator UNKNOWN

• Anxi County Hospital

  collaborator UNKNOWN

• Nanan Hospital

  collaborator UNKNOWN

• MinDong Hospital of Ningde City

  collaborator UNKNOWN

• Affiliated Hospital of Putian University

  collaborator UNKNOWN

• Lianjiang County Hospital

  collaborator UNKNOWN

• Shunchang County Hospital

  collaborator UNKNOWN

• Yulin No.2 Hospital

  collaborator OTHER

• The First Affiliated Hospital of Xiamen University

  collaborator OTHER

• The Second Affiliated Hospital of Xiamen Medical College

  collaborator UNKNOWN

• Zhangzhou Municipal Hospital of Fujian Province

  collaborator OTHER

• Longyan People's Hospital of Fujian Province

  collaborator UNKNOWN

• First Affiliated Hospital of Fujian Medical University

  lead OTHER

Principal Investigators

• Kang Dezhi, MD. · The first affilicated hospital of Fujian Medical univercity

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-31

Primary Completion

2025-08-31

Completion

2025-09-30

Countries

• China

Study Locations