Chronic Subdural Hematoma Treatment With Intra-Arterial Bevacizumab Injection

Официальное название

Chronic Subdural Hematoma Treatment With Avastin® (Bevacizumab) Intra-Arterial Injection: A Non-Randomized, Open-Label Phase 1/2 Clinical Trial

Обзор

The goal of this clinical trial is to test whether infusing bevacizumab into the middle meningeal arteries can be used to treat chronic subdural hematomas (cSDH). The main questions it aims to answer are: * Is bevacizumab infusion safe in cSDH patients? * Is bevacizumab infusion effective in treating cSDH?

Вмешательства

• Препарат Bevacizumab 2 mg/kg
  Single 2mg/kg dose of bevacizumab to treat unilateral cSDH
• Препарат Bevacizumab 4 mg/kg
  Two 2mg/kg doses (cumulatively 4mg/kg) of bevacizumab to treat bilateral cSDH

Первичные конечные точки

• Number of Participants with Serious Adverse Events [Срок оценки: Up to 3 months after study treatment]

Вторичные конечные точки (7)

• Rate of Hematoma Recurrence [Срок оценки: 3 months after study treatment and 6 months after study treatment]
• Rate of Complete Hematoma Resolution [Срок оценки: 3 months after study treatment and 6 months after study treatment]
• Rate of Partial Hematoma Resolution [Срок оценки: 3 months after study treatment and 6 months after study treatment]
• Change in Hematoma Size [Срок оценки: 3 months after study treatment and 6 months after study treatment]
• Change in Clinical Neurological Symptom Scale Scores: NIHSS [Срок оценки: 3 months after study treatment and 6 months after study treatment]
• Change in Clinical Neurological Symptom Scale Scores: GCS [Срок оценки: 3 months after study treatment and 6 months after study treatment]
• Change in Clinical Neurological Symptom Scale Scores: mRS [Срок оценки: 3 months after study treatment and 6 months after study treatment]

Критерии участия

Критерии включения

• Adult patients (≥18 years)
• Radiographic evidence of chronic subdural hematoma, including

• Persistence of subdural blood more than 10 days after index traumatic injury or event
• Presence of mixed density blood
• Presence of subdural membranes
• Can obtain informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization.

Критерии исключения

• Pregnant, breastfeeding, or unwilling to practice contraception during participation in the study.
• Patients with concomitant intracranial pathology other than subdural hematoma (e.g., intracranial malignancy).
• Patients with known hypersensitivity to bevacizumab.
• Patients with radiographic evidence of mass effect.
• Patients have focal neurological deficits attributed to subdural hematoma.
• Patient had craniotomy or burr hole operative procedures performed in preceding two weeks prior to onset of subdural hematoma.
• Secondary causes apart from trauma for the chronic subdural hematoma, such as underlying vascular abnormality or tumor.
• Emergent surgical evacuation is required for the patient.
• Non-convexity chronic subdural hematoma, as the middle meningeal artery will not supply this area.
• Coagulation abnormalities, including platelet count <100,000 and/or international normalized ratio of <1.5 despite attempts for correction.
• Patients with known contraindications for angiography. Patients with contrast allergy will be premedicated with diphenhydramine and steroids.
• Patient has known active systemic infection or sepsis.
• Patient has contradiction to anesthetic agents used for conscious sedation/monitored anesthesia care (MAC).
• Patient has life expectancy of less than six months due to comorbid terminal conditions.
• Patient has a premorbid modified Rankin score (mRS) of 5 or greater.
• Concurrent participation in another research protocol for investigation of an experimental therapy.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Cooper University Health Care — Camden

Публикации

• Khalife J, Tonetti DA, Shaikh H, Jovin T, Patel P, Thomas A. Intraarterial Bevacizumab Administration Through the Middle Meningeal Artery for Chronic Subdural Hematoma. Stroke Vasc Interv Neurol. 2023 Feb 25;3(4):e000722. doi: 10.1161/SVIN.122.000722. eCollection 2023 Jul. PMID 41583665
• Khalife J, Koneru M, Tonetti DA, Shaikh HA, Jovin TG, Patel PD, Thomas AJ. Intra-arterial Selective Bevacizumab Administration in the Middle Meningeal Artery for Chronic Subdural Hematoma: An Early Experience in 12 Hemispheres. Stroke Vasc Interv Neurol. 2024 Jul 22;4(5):e001409. doi: 10.1161/SVIN.124.001409. eCollection 2024 Sep. PMID 41586284

Идентификаторы

NCT: NCT06510582 · 23-154

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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