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临床试验/NCT07118631
NCT07118631招募中不适用

Clinical Study on Emergency Treatment of Cerebral Arteriovenous Malformation Bleeding and Continuous Improvement of Medical Quality Based on Neurosurgery Hybrid Surgery Platform

Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
162
试验地点
1
主要终点
Neurological outcomes

研究概览

简要总结

Cerebral arteriovenous malformation (AVM) is the leading cause of brain hemorrhage in young adults, characterized by sudden onset and rapid progression. The hybrid neurosurgical operating room is a diagnostic and therapeutic platform that integrates neurointervention and microneurosurgery, offering advantages such as one-stop rapid treatment and multimodal therapeutic approaches.

This study aims to focus on patients with acute cerebral AVM-related hemorrhage through a multicenter, prospective, registry-based research approach. In the hybrid neurosurgical operating room, emergency cerebral angiography, neurointerventional embolization, microsurgical resection of the vascular malformation, or minimally invasive hematoma evacuation will be performed to explore the indications and advantages of the hybrid neurosurgical operating platform in emergency AVM hemorrhage management. The study seeks to establish standardized diagnostic and treatment protocols and operational workflows for emergency AVM hemorrhage management in the hybrid operating room. Through continuous quality improvement, the study aims to further reduce patient morbidity and mortality.

This research will not only enhance the diagnostic and therapeutic level of cerebral AVM-related hemorrhage and improve patient outcomes but also effectively reduce medical costs and societal burdens.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Head CT confirmed cerebral hemorrhage, with indications for emergency surgery
  • Head CTA suggested that the responsible lesion may be cerebral arteriovenous malformation
  • Spetzler-Martin classification 1 to 4; Cerebral arteriovenous malformation Spetzler-Martin classification is as follows: ① Nidus size: small (<3 cm) is scored as 1 point, medium (3 cm~6 cm) is scored as 2 points, and large (≥6 cm) is scored as 3 points; ② Adjacent brain functional areas: 0 points for non-functional areas, 1 point for functional areas; ③ Drainage veins: 0 points for superficial veins, 1 point for deep veins);
  • Aged 18 to 70 years old, with systemic conditions that can tolerate surgery;
  • Agree to surgical treatment and sign an informed consent form.

排除标准

  • Consciousness disorder due to serious underlying diseases
  • Patients or family members who refuse surgery
  • Perinatal and pregnancy patients

结局指标

主要结局

Neurological outcomes

时间窗: 2 weeks, 3 months, 6 months after surgery

modified rankin scale (mRS), The scale runs from 0-6. Higher scores mean a worse outcome

次要结局

  • surgical information(pre-surgery, during the surgery, perioperatively immediately after the surgery)
  • Complications(2 weeks, 3 months, 6 months after surgery)

研究者

发起方
Beijing Tiantan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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