By InvitationNot Applicable

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

China750 participantsStarted 2025-01-16

Plain-language summary

The objective of this study is to determine whether minimally invasive soft channel brain hemorrhage evacuation (scMIS), compared to usual care, leads to superior functional recovery as measured by utility-weighted modified Rankin Scale (UW-mRS) scores at 6 months in patients with basal ganglia intracerebral hemorrhage (ICH) of 20 ≤ volume ≤ 30 ml.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Adults (18 - 80 years) ;
✓. The clinical diagnosis is acute intracerebral hemorrhage, confirmed by imaging;
✓. Onset within 48 hours, and surgery can be initiated within 48 hours;
✓. Basal ganglia hemorrhage, with a bleeding volume of 20 ≤ volume ≤ 30 ml;
✓. Reduced level of consciousness (GCS 9-14);
✓. Pre-stroke mRS score≤1 points;
✓. Systolic blood pressure \<140 mmHg before randomisation;
✓. Informed consent obtain accordingly to local regulations.

Exclusion criteria

✕. 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.
✕. A high likelihood that the patient will not adhere to the study treatment and follow-up regimen.
✕. Platelet count \< 100,000, INR \> 1.4.

What they're measuring

Functional recovery according to UW-mRS assessed at 6 months

Timeframe: 6 months

Trial details

NCT IDNCT06688162

SponsorCapital Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-30

View on ClinicalTrials.gov More Intracerebral Hemorrhage trials