A Multicenter, RAndomlzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-assisted Robotic guidanCe for Hemorrhagic Stroke: Large Basal Ganglia Hemorrhage

Обзор

This substudy is a prospective, multicenter, parallel-controlled, randomized controlled trial designed to evaluate whether robot-assisted endoscopic evacuation of large basal ganglia hematomas can improve patient outcomes compared with traditional surgical approaches such as small craniotomy or large-bone-flap intracranial hematoma evacuation.

Подробное описание

This substudy adopts an open-label design, while outcome assessment is performed in a blinded manner. The primary outcome is the modified Rankin Scale (mRS) at 6 months. Outcomes at 30 days, 90 days, and 6 months will also be assessed. Follow-up will be conducted at baseline; 24 hours after surgery/ 30 hours after randomization; 48 hours; Day 3; Day 14 or at discharge; Day 30; Day 90; and Month 6. During follow-up, data will be collected on mortality, survival, ambulation status, living situation, modified Rankin Scale, EQ-5D-5L, Fatigue Severity Scale, AD8, Lawton-Brody Instrumental Activities of Daily Living Scale, National Institutes of Health Stroke Scale (NIHSS), Glasgow Coma Scale, laboratory tests, and neuroimaging findings.

Вмешательства

• Процедура Robot-Assisted Endoscopic Minimally Invasive Surgery
  Neurosurgeons participating in the robot-assisted endoscopic procedure must be qualified doctors who have completed standardized training and certification by the coordinating center. They must be capable of performing endoscopic hematoma evacuation and managing common intraoperative complications. Each certified surgeon is required to regularly review the surgical protocol and the technical components of the procedure. Surgical trajectory: The incision and burr-hole location are determined usi
• Процедура Traditional Surgical Approaches
  A small craniotomy or large bone flap craniotomy is performed to microscopically evacuate the basal ganglia hematoma, followed by electrocoagulation for hemostasis. Depending on preoperative brain herniation or intraoperative brain swelling, the surgeon may decide whether to remove the bone flap.

Первичные конечные точки

• Modified Rankin Scale (mRS) score at 6 months [Срок оценки: up to 6 months]

Вторичные конечные точки (11)

• Ordinal shift in mRS scores at 6 months (ordinal shift) [Срок оценки: up to 6 months]
• Favorable functional outcome at 6 months (mRS 0-1) [Срок оценки: up to 6 months]
• Functional independence at 6 months (mRS 0-2) [Срок оценки: up to 6 months]
• Health-related quality of life (HRQoL) at 6 months, assessed by the EQ-5D-5L questionnaire [Срок оценки: up to 6 months]
• Total length of hospital stay [Срок оценки: up to 6 months]
• Cognitive function at 6 months [Срок оценки: up to 6 months]
• Hematoma clearance rate at 48 hours postoperatively [Срок оценки: up to 6 months]
• Costs during hospitalization [Срок оценки: up to 6 months]
• Intraoperative blood loss [Срок оценки: up to 6 months]
• Incidence of rebleeding within 14 days [Срок оценки: up to 6 months]
• Incidence of related complications within 14 days, including pulmonary infection, aphasia, seizures, and deep vein thrombosis of the lower limbs [Срок оценки: up to 6 months]

Критерии участия

Критерии включения

• Age ≥18 years at randomization;
• Diagnosed with hypertensive basal ganglia hemorrhage via imaging (CT, CTA, etc.);
• Hematoma volume ≥30 mL prior to randomization;
• Glasgow Coma Scale (GCS) score ≥ 5;
• Available for surgery within 72 hours after onset;
• Modified Rankin Scale (mRS) score ≤ 1 prior to this hemorrhage;
• Informed consent obtained in accordance with national laws, regulations, and applicable ethics committee requirements.

Критерии исключения

• Hematoma involving the thalamus (volume >5 mL or diameter >2 cm), midbrain, or ventricles (Graeb score ≥3), or other locations;
• Radiologically confirmed cerebral vascular abnormalities including ruptured aneurysms, arteriovenous malformations (AVMs), or Moyamoya disease; hemorrhagic transformation of ischemic infarcts; or recent (within 1 year) recurrence of intracerebral hemorrhage;
• Signs of impending herniation such as midline shift exceeding 1 cm or ipsilateral pupillary changes;
• Any irreversible coagulation disorder or known coagulopathy; platelet count <100,000; INR >1.4; or use of anticoagulant medication within 7 days before the current hemorrhage;
• Current or probable pregnancy;
• Patients with concurrent severe illness likely to influence outcome assessment;
• Difficulty in follow-up or poor compliance due to any cause.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Affiliated Drum Tower Hospital of Nanjing University Medical School — Нанкин

Идентификаторы

NCT: NCT06484374 · SQ2023AAA030147

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗