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NCT Number: NCT07118631

Clinical Study on Emergency Treatment of Cerebral Arteriovenous Malformation Bleeding

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.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Neurological outcomes

    Time frame: 2 weeks, 3 months, 6 months after surgery

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

Secondary outcomes

  1. surgical information

    Time frame: pre-surgery, during the surgery, perioperatively immediately after the surgery

  2. Complications

    Time frame: 2 weeks, 3 months, 6 months after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Yuming Jiao, MD

CONTACT

[email protected]

86-15010108242

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 12, 2025
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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