Clinical Study on Emergency Treatment of Cerebral Arteriovenous Malformation Bleeding
NCT ID: NCT07118631
Last Updated: 2025-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
162 participants
OBSERVATIONAL
2025-04-01
2028-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Hybrid surgery cohort
After patients were enrolled, they were admitted to the hybrid operating room for DSA to confirm the diagnosis. If the patient meets the surgical indications, one-stop treatment with composite surgery will be performed. During the operation, the treatment plan is determined based on the characteristics of the malformation group, including simple embolization, partial embolization, auxiliary embolization for arteriovenous malformation resection, and the target area and proportion of embolization. For those who need craniotomy, the hematoma is removed during the operation and the brain arteriovenous malformation is removed under a microscope. Intraoperative ultrasound assists in locating the location, boundaries and residue of the malformation. Head DSA was reviewed immediately after surgery. Further clarify whether the lesions are completely removed. If the lesion remains, immediate surgical treatment and subsequent DSA review will be perfor
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients or family members who refuse surgery
* Perinatal and pregnancy patients
18 Years
70 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Responsible Party
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Locations
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Beijing Tiantan Hospital, Capital Medical University
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BRWEP2024W022040104
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
BRWEP2024W022040104
Identifier Type: -
Identifier Source: org_study_id
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