Arteriovenous MalformationNCT07118631
Clinical Study on Emergency Treatment of Cerebral Arteriovenous Malformation Bleeding
An observational study of Arteriovenous Malformation and Bleeding, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Arteriovenous Malformation, Bleeding
- How many people
- 162 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 31 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with mergency cerebral arteriovenous malformation bleeding
Who may be able to join
- 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.
Who cannot join
- Consciousness disorder due to serious underlying diseases
- Patients or family members who refuse surgery
- Perinatal and pregnancy patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, 100070
Yuming Jiao, 86-15010108242, shengxiongyuming@163.com
About this study
Official title: Clinical Study on Emergency Treatment of Cerebral Arteriovenous Malformation Bleeding and Continuous Improvement of Medical Quality Based on Neurosurgery Hybrid Surgery Platform
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
- Medical subject headings
- Arteriovenous Malformations, Hemorrhage, Cerebral Hemorrhage, Intracranial Arteriovenous Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological outcomes
modified rankin scale (mRS), The scale runs from 0-6. Higher scores mean a worse outcome
Measured: 2 weeks, 3 months, 6 months after surgery
Secondary outcomes (2)
surgical information
Measured: pre-surgery, during the surgery, perioperatively immediately after the surgery
Complications
Measured: 2 weeks, 3 months, 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 Apr 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous MalformationStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118631
- Sponsor's protocol ID
- BRWEP2024W022040104
- Other IDs
- BRWEP2024W022040104
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Emergency Treatment of Cerebral Arteriovenous Malformation Bleeding and Continuous Improvement of Medical Quality Based on Neurosurgery Hybrid Surgery Platform
- ClinicalTrials.gov ID
- NCT07118631
- Acronym / sponsor ID
- BRWEP2024W022040104
- Conditions
- Arteriovenous Malformation, Bleeding
- Keywords
- Cerebral hemorrhage, cerebral arteriovenous malformation, hybrid surgery, functional prognosis, quality improvement system
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with mergency cerebral arteriovenous malformation bleeding
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Consciousness disorder due to serious underlying diseases
- Patients or family members who refuse surgery
- Perinatal and pregnancy patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arteriovenous Malformation and Bleeding, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuming Jiao, MD (86-15010108242, shengxiongyuming@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological outcomes (time frame: 2 weeks, 3 months, 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.