The Effectiveness and Safety of Body Posture in Preventing Postoperative Recurrence for Chronic Subdural Hematoma

Официальное название

The Effectiveness and Safety of Body Posture to Improve Intracranial Pressure in Preventing Postoperative Recurrence for Chronic Subdural Hematoma (BP-CSDH) -A Multicenter Randomized Controlled Clinical Trial

Обзор

This study aims to investigate the effectiveness and safety of body posture to improve intracranial pressure in preventing postoperative recurrence for chronic subdural hematoma

Подробное описание

The BP-CSDH study is a prospective, multicentre, open-label, randomised controlled trial with blinded endpoint assessment. 830 eligible patients will be randomised 1:1 to body posture therapy group or the control group. Follow-up assessments will be conducted at 30 days (±7 days), 90 days (±10 days) and 365 days(±30 days) post-surgery.

Вмешательства

• Поведенческое Intracranial Hypotension Targeted(IHT) Body Posture
  IHT therapy requires CSDH patients to raise their lower limbs 30° higher over the horizontal level of their head.For patients with unilateral CSDH, the head should be tilted towards the hematoma affected side and opposite side lying should be avoided as much as possible. For patients with bilateral CSDH, there is no need for the head lateralization.To avoid food reflux and aspiration pneumonia, IHT therapy was strictly prohibited within 2 hours after each meal

Первичные конечные точки

• subdural hematoma recurrence rate [Срок оценки: within 90±10 days post-surgery]

Вторичные конечные точки (3)

• change in modified Rankin Scale(mRS) compared to baseline [Срок оценки: 90±10 days post-surgery]
• change in EQ-5D-5L score compared to baseline [Срок оценки: 90±10 days post-surgery]
• change in MGS-GCS score compared to baseline [Срок оценки: 90±10 days post-surgery]

Критерии участия

Критерии включения

• chronic subdural hematoma is diagnosed with CT/MRI scan; thickness of hematoma is more than 1 cm;
• more than 60 years of age or 60 years;
• MGS-GCS (Markwalder's Grading Scale and Glasgow Coma Scale) is less than or equal to 2;
• patients have neurological symptom caused by CSDH before surgery, such as headache, dizziness, nausea, vomiting, numbness or weakness of limb, instability to walk, unconsciousness, trouble speaking, insensitive, etc.
• receive burr hole drainage;
• sign informed consent voluntarily.

Критерии исключения

• have brain hernia or acute massive cerebral infarction that have to perform craniotomy
• have severe malignancies, hemorrhagic disease, cardiac dysfunction and other serious disease that may impede recovery or follow-up compliance;
• Spinal deformities (e.g., kyphosis) or psychiatric disorders precluding prolonged body posture therapy adherence
• Concomitant severe intracranial tumors, aneurysms, or vascular malformations that may impede recovery.
• Patients with cranial CT demonstrating no significant compression or displacement of brain tissue, asymptomatic presentation, and unaffected daily activities were deemed ineligible for surgical intervention by neurosurgeons;
• CSDH persisting for over 1 year and exhibiting marked organization/solidification of the hematoma;
• CSDH caused by over V-P shunting;
• during burr hole drainage, patients have to perform craniotomy due to acute bleeding or brain hernia;
• Intraoperative complications (e.g., cerebral contusion, intraparenchymal catheter placement) during burr hole drainage;
• have deep venous thrombosis of lower extremity or pulmonary embolism;
• cannot complete regular reexamine within 1 year for any reason;
• life expectancy less than 1 year;
• participating other ongoing clinical trial;
• patients are not qualified for other reason evaluated by two neurosurgeons;
• have bile reflux gastritis and esophageal diseases.

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

Профилактика

Центры проведения

Китай · 1 центр

• Department of Neurosurgery, Huashan Hospital, Fudan University — Шанхай

Идентификаторы

NCT: NCT06401772 · KY2024-599

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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