Clinical Study on Emergency Treatment of Cerebral Arteriovenous Malformation Bleeding

NCT07118631 | Recruiting DMC

• 1 other identifier: BRWEP2024W022040104
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arteriovenous Malformation; Bleeding

Keywords

Cerebral hemorrhage; cerebral arteriovenous malformation; hybrid surgery; functional prognosis; quality improvement system

Outcome Measures

Primary Outcomes (1)

• Neurological outcomes

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

  2 weeks, 3 months, 6 months after surgery

Secondary Outcomes (2)

• surgical information

  pre-surgery, during the surgery, perioperatively immediately after the surgery

• Complications

  2 weeks, 3 months, 6 months after surgery

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with mergency cerebral arteriovenous malformation bleeding

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, 100070, China

RECRUITING

MeSH Terms

Conditions

Arteriovenous Malformations; Hemorrhage; Cerebral Hemorrhage; Intracranial Arteriovenous Malformations

Condition Hierarchy (Ancestors)

Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Central Nervous System Vascular Malformations; Nervous System Malformations; Intracranial Arterial Diseases

Central Study Contacts

Yuming Jiao, MD

CONTACT

86-15010108242; shengxiongyuming@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 12, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: August 12, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)