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

Обзор

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.

Вмешательства

• Другое Usual Care
  During the study treatment and follow-up periods, patients are to receive usual standard of care according to published guidelines for acute stroke care. It is anticipated that background care may include the use of other treatments including drugs and interventions.
• Процедура Minimally Invasive Soft Channel Brain Haemorrhage Evacuation (scMIS)
  This technique is based on the study of hematoma anatomy, cerebral vascular anatomy, and neural fiber structure anatomy in basal ganglia hemorrhage to determine the optimal surgical (catheter insertion) path. By applying stereogeometric principles, it allows for simple yet precise localization. Through surgical steps including puncture, aspiration, liquefaction (intermittent infusion of urokinase or alteplase), and external drainage, the hematoma can be completely removed in stages over a short

Первичные конечные точки

• Functional recovery according to UW-mRS assessed at 6 months [Срок оценки: 6 months]

Вторичные конечные точки (9)

• Discharge at Day 7 (yes vs. no) [Срок оценки: 7 days after randomization]
• Total length of intensive care unit stay. [Срок оценки: During hospitalisation up to 6 months after randomization]
• Ordinal analysis of modified Rankin Scale [mRS] scores at 28 days [Срок оценки: 28 days after randomization]
• The following at 6-months: ordinal analysis of modified Rankin Scale [mRS] scores 3-6 [Срок оценки: 6-months after randomization]
• The following at 6-months: ordinal analysis of modified Rankin Scale [mRS] scores 3-5 [Срок оценки: 6-months after randomization]
• The following at 6-months: ordinal analysis of modified Rankin Scale [mRS] scores 0-6 [Срок оценки: 6-months after randomization]
• The following at 6-months: AMC Linear Disability Score(ALDs) [Срок оценки: 6-months after randomization]
• The following at 6-months: EuroQoL Group 5-Dimension self-report questionnaire (EQ-5D) [Срок оценки: 6-months after randomization]
• Days of hospitalization [Срок оценки: During hospitalisation up to 6 months after randomization]

Критерии участия

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Capital Medical University — Пекин

Идентификаторы

NCT: NCT06688162 · MIRACLE-S

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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