Actively Recruiting
Clinical Study on Emergency Treatment of Cerebral Arteriovenous Malformation Bleeding and Continuous Improvement of Medical Quality Based on Neurosurgery Hybrid Surgery Platform
Led by Beijing Tiantan Hospital · Updated on 2025-08-12
162
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on patients with acute cerebral arteriovenous malformation (AVM) bleeding, a leading cause of brain hemorrhage in young adults characterized by sudden onset and rapid progression. The study evaluates the use of a hybrid neurosurgical operating room that combines neurointervention and microneurosurgery to improve emergency treatment for cerebral AVM-related hemorrhage. Through a multicenter, prospective, registry-based approach, the study aims to establish standardized protocols and workflows for this emergency treatment. Participants admitted to the hybrid operating room first undergo emergency cerebral angiography to confirm diagnosis. If suitable for surgery, they receive one-stop composite surgery, which may include neurointerventional embolization, microsurgical removal of the vascular malformation, or minimally invasive hematoma evacuation. The treatment plan is tailored during surgery based on the characteristics of the malformation, and intraoperative ultrasound helps locate the lesion and assess removal completeness. Head digital subtraction angiography (DSA) is reviewed immediately after surgery to confirm treatment success or determine further intervention. Participants are monitored with neurological outcome assessments at 2 weeks, 3 months, and 6 months after surgery. Surgical information and any complications are collected before, during, and shortly after surgery, as well as during follow-up visits. The study aims to improve patient outcomes while reducing medical costs and societal burdens by continuously enhancing the quality of emergency AVM hemorrhage management using the hybrid neurosurgical platform. The total study duration includes these follow-up periods to comprehensively evaluate treatment impact.
CONDITIONS
Brief Title
Clinical Study on Emergency Treatment of Cerebral Arteriovenous Malformation Bleeding
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Head CT confirmed cerebral hemorrhage with indications for emergency surgery
- Head CTA suggests cerebral arteriovenous malformation as the responsible lesion
- Spetzler-Martin classification of the malformation between 1 and 4
- Aged 18 to 70 years with systemic health able to tolerate surgery
- Agree to surgical treatment and provide informed consent
You will not qualify if you...
- Consciousness disorder caused by serious underlying diseases
- Patient or family refusal of surgery
- Patients who are pregnant or in the perinatal period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospital stay during surgery and immediate recovery period
Participants undergo hybrid surgery involving DSA diagnosis and composite surgical treatment including embolization and craniotomy if needed. Intraoperative ultrasound and immediate post-surgery DSA are used to assess lesion removal and guide further treatment.
Surgery day and immediate post-operative assessments in hospital
Duration - Up to 6 months after surgery
Participants are monitored for neurological outcomes and complications following surgery with evaluations at multiple time points.
Visits at 2 weeks, 3 months, and 6 months after surgery
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital, Capital Medical University
Beijing, China, 100070
Actively Recruiting
Research Team
Y
Yuming Jiao, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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