Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06688201

Minimally Invasive Soft Channel Brain Hemorrhage Evacuation for Acute Basal Ganglia Hemorrhage Compared to Other Neurosurgical Techniques

Led by Capital Medical University · Updated on 2025-01-07

550

Participants Needed

1

Research Sites

103 weeks

Total Duration

On this page

Sponsors

C

Capital Medical University

Lead Sponsor

L

Linyi People's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether minimally invasive soft channel brain hemorrhage evacuation (scMIS) is at least as effective as other neurosurgical techniques, including open craniotomy, small skull window microsurgery, and endoscopic surgery, for treating acute basal ganglia intracerebral hemorrhage (ICH) with a volume between 30 and 100 ml. The study aims to compare these methods based on the clinical outcome of death or major disability six months after treatment. This trial focuses on patients with reduced consciousness levels and blood pressure below 140 mmHg before randomization. The minimally invasive soft channel technique uses detailed knowledge of brain anatomy to find the best surgical path for catheter insertion. This procedure involves puncture, aspiration, liquefaction using intermittent infusion of medications like urokinase or alteplase, and external drainage to gradually remove the hematoma while reducing brain pressure. The comparison group includes other neurosurgical methods selected by the attending clinician based on hospital expertise and availability. Participants will be monitored for six months after randomization to assess outcomes of death or major disability using the modified Rankin Scale (mRS). The study includes clinical diagnosis confirmation by imaging, informed consent, and blood pressure control before surgery. Researchers will track the effectiveness and safety of the treatments during this period, focusing on recovery and disability levels.

CONDITIONS

Official Title

Minimally Invasive Soft Channel Brain Haemorrhage Evacuation for Acute Basal Ganglia Haemorrhage-- Large Hemorrhage Evacuation (MIRACLE-L)

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 80 years
  • Clinical diagnosis of acute intracerebral hemorrhage confirmed by imaging
  • Stroke symptoms started within 48 hours and surgery can start within 48 hours
  • Basal ganglia hemorrhage with bleeding volume greater than 30 ml and up to 100 ml
  • Reduced level of consciousness with Glasgow Coma Scale score between 4 and 14
  • Pre-stroke modified Rankin Scale score of 1 or less
  • Systolic blood pressure less than 140 mmHg before randomization
  • Able to receive either minimally invasive soft channel surgery or other neurosurgical techniques
  • Informed consent obtained according to local regulations
Not Eligible

You will not qualify if you...

  • Intracerebral hemorrhage caused by brain structural abnormalities such as arteriovenous malformation, aneurysm, tumor, trauma, cerebral venous thrombosis, or previous thrombolysis or neurointerventional surgery
  • High likelihood of not following the study treatment or follow-up
  • Platelet count less than 100,000 or INR greater than 1.4

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Linyi People's Hospital

Linyi, Shandong, China, 276000

Actively Recruiting

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Research Team

X

XunMing Ji, PhD

H

HeTao Bian, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Frequently Asked Questions

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