Minimally invasive procedure for brain hemorrhage evacuation

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

This study is testing a new, less invasive surgery for brain bleeding to see if it helps adults with certain types of hemorrhages do better than traditional surgery methods.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 550 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Capital Medical University (other)
• Locations: 1 site (Linyi, Shandong)
• Trial ID: NCT06688201 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with acute basal ganglia intracerebral hemorrhage and a hemorrhage volume between 30 and 100 ml.

Not a fit: Patients with hemorrhages secondary to structural brain abnormalities or those with a high likelihood of non-adherence to treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved outcomes for patients suffering from acute intracerebral hemorrhage by providing a less invasive treatment option.

How similar studies have performed: Other studies have shown promising results with minimally invasive techniques for brain hemorrhage evacuation, suggesting potential for success in this approach.

Eligibility criteria

* 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 this trial is running

Linyi, Shandong

• Linyi People's Hospital — Linyi, Shandong, China (RECRUITING)

Study contacts

• Principal investigator: XunMing Ji, PhD — Capital Medical University
• Study coordinator: XunMing Ji, PhD

Conditions: Intracerebral Hemorrhage