NCT06510582招募中1 期
Chronic Subdural Hematoma Treatment With Avastin® (Bevacizumab) Intra-Arterial Injection: A Non-Randomized, Open-Label Phase 1/2 Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Number of Participants with Serious Adverse Events
研究概览
简要总结
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?
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Phase 1 Unilateral cSDH/ 2mg/kg Arm
Experimental
During phase 1, single 2mg/kg dose of bevacizumab to treat unilateral cSDH
干预措施: Bevacizumab 2 mg/kg (Drug)
Phase 1 Bilateral cSDH/ 4mg/kg Arm
Experimental
During phase 1, two 2mg/kg doses (cumulatively 4mg/kg) of bevacizumab to treat bilateral cSDH
干预措施: Bevacizumab 4 mg/kg (Drug)
Phase 2 Unilateral cSDH/ 2mg/kg Arm
Experimental
During phase 2, single 2mg/kg dose of bevacizumab to treat unilateral cSDH
干预措施: Bevacizumab 2 mg/kg (Drug)
Phase 2 Bilateral cSDH/ 4mg/kg Arm
Experimental
During phase 2, two 2mg/kg doses (cumulatively 4mg/kg) of bevacizumab to treat bilateral cSDH
干预措施: Bevacizumab 4 mg/kg (Drug)
结局指标
主要结局
Number of Participants with Serious Adverse Events
时间窗: Up to 3 months after study treatment
Reported serious adverse events classified using MedDRA and CTCAE, in addition to treatment-related events and all other adverse events
次要结局
- Rate of Hematoma Recurrence(3 months after study treatment and 6 months after study treatment)
- Rate of Complete Hematoma Resolution(3 months after study treatment and 6 months after study treatment)
- Change in Clinical Neurological Symptom Scale Scores: GCS(3 months after study treatment and 6 months after study treatment)
- Rate of Partial Hematoma Resolution(3 months after study treatment and 6 months after study treatment)
- Change in Hematoma Size(3 months after study treatment and 6 months after study treatment)
- Change in Clinical Neurological Symptom Scale Scores: NIHSS(3 months after study treatment and 6 months after study treatment)
- Change in Clinical Neurological Symptom Scale Scores: mRS(3 months after study treatment and 6 months after study treatment)
研究者
Jane Khalife, MD
Assistant Professor of Neurology
The Cooper Health System
研究点 (1)
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