Minimally-invasive Surgery Versus Craniotomy in Patients With Supratentorial Hypertensive Intracerebral Hemorrhage

Summary

The effectiveness of craniotomy in the treatment of intracerebral hemorrhage remains controversial. Two main types of minimally invasive surgery, endoscopic evacuation and stereotactic aspiration, have been attempted for hematoma removal and show some advantages. However, prospective and controlled studies are still lacking. This is a multi-center randomized controlled trial designed to determine whether minimally invasive hematoma evacuation with endoscopic or stereotactic aspiration will improve the outcome in patients with hypertensive intracerebral hemorrhage compared with small-boneflap craniotomy. Patients will be randomly assigned to endoscopy group, stereotactic aspiration group or small-boneflap craniotomy group in a 1:1:1 ratio.

Conditions

• Intracranial Hemorrhage, Hypertensive

Interventions

PROCEDURE

Endoscopic Evacuation

Endoscopic surgery for treatment of supratentorial hypertensive intracerebral hemorrhage.

PROCEDURE

Stereotactic Aspiration

Using image guidance to aspirate hematoma.

PROCEDURE

Craniotomy

Craniotomy with a big bone flap to evacuate intracerebral hematoma.

Sponsors & Collaborators

• Jingzhou Central Hospital

  collaborator OTHER

• Wuhan No.1 Hospital

  collaborator OTHER

• Yichang Central People's Hospital

  collaborator OTHER

• Second Hospital of Jilin University

  collaborator OTHER

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• Second Affiliated Hospital of Nanchang University

  collaborator OTHER

• Tang-Du Hospital

  collaborator OTHER

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Jiangmen Central Hospital

  collaborator OTHER

• Jilin Province People's Hospital

  collaborator UNKNOWN

• Siping Central People's Hospital

  collaborator OTHER

• Minzu Hospital of Guangxi Zhuang Autonomous Region

  collaborator UNKNOWN

• Taihe Hospital

  collaborator OTHER

• Chinese PLA General Hospital

  lead OTHER

Principal Investigators

• Xiaolei Chen, MD · Chinese PLA General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-07-01

Primary Completion

2022-06-30

Completion

2022-07-31

Countries

• China

Study Locations