Minimally invasive procedure for brain hemorrhage evacuation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of a minimally invasive soft channel brain hemorrhage evacuation technique compared to traditional neurosurgical methods such as open craniotomy and endoscopic surgery. It focuses on patients with acute basal ganglia intracerebral hemorrhage, specifically those with a hemorrhage volume between 30 and 100 ml. The primary outcome measure is the rate of poor clinical outcomes, defined as death or major disability, at six months post-surgery. The study will enroll adults aged 18 to 80 who meet specific clinical criteria and can undergo surgery within 48 hours of symptom onset.

Why it matters

Who can join: the full rules

* Inclusion Criteria:

  1. Adults (18 - 80 years) ;
  2. The clinical diagnosis is acute intracerebral hemorrhage, confirmed by imaging;
  3. Onset within 48 hours, and surgery can be initiated within 48 hours;
  4. Basal ganglia hemorrhage, with a bleeding volume of 30 \< volume ≤ 100 ml;
  5. Reduced level of consciousness (GCS 4-14);
  6. Pre-stroke mRS score≤1 points;
  7. Systolic blood pressure \<140 mmHg before randomisation;
  8. Availability of being able to receive either scMIS or other neurosurgical technique;
  9. Informed consent obtain accordingly to local regulations.
* Exclusion Criteria:

  1. Definite evidence the ICH is secondary to a structural abnormality in the brain (eg arteriovenous malformation, intracranial aneurysm, tumour, trauma, cerebral venous thrombosis) or previous thrombolysis or neurointerventional surgery.
  2. A high likelihood that the patient will not adhere to the study treatment and follow-up regimen.
  3. Platelet count \< 100,000, INR \> 1.4.

Where it's running

• Linyi People's Hospital
  Linyi, Shandong, China Recruiting

Study contacts

• Principal investigator: XunMing Ji, PhD — Capital Medical University
• Study coordinator: XunMing Ji, PhD
• Email: jixm@ccmu.edu.cn
• Phone: +8613911077166

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.