Clinical Study on Emergency Treatment of Cerebral Arteriovenous Malformation Bleeding
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Arteriovenous Malformation, Bleeding. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Study on Emergency Treatment of Cerebral Arteriovenous Malformation Bleeding and Continuous Improvement of Medical Quality Based on Neurosurgery Hybrid Surgery Platform
Overview
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.
Primary outcome measures
- Neurological outcomes [Time frame: 2 weeks, 3 months, 6 months after surgery]
Secondary outcome measures (2)
- surgical information [Time frame: pre-surgery, during the surgery, perioperatively immediately after the surgery]
- Complications [Time frame: 2 weeks, 3 months, 6 months after surgery]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Consciousness disorder due to serious underlying diseases
- Patients or family members who refuse surgery
- Perinatal and pregnancy patients
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Beijing Tiantan Hospital, Capital Medical University — Beijing
Identifiers
NCT: NCT07118631 · BRWEP2024W022040104 · BRWEP2024W022040104