Registry of Multimodality Treatment for Brain Arteriovenous Malformation in Mainland China

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

This study is a multi-center, prospective, registry study. This research was supported by the National Key Research and Development Program. They were divided into experimental group and control group according to whether the treatment plan was formulated by a multidisciplinary team. Patients of experimental group is strictly in accordance with standardized multi-disciplinary treatment protocols and meet the following criteria: 1. A multi-disciplinary conference discussion; 2. Detailed preoperative evaluation based on CT, MRI, fMRI and DSA. 3. Treatment modalities meet the following treatment criteria(craniotomy, embolization and stereotactic radiosurgery). The control group was patients who had not been treated according to a multi-disciplinary treatment protocol. Patient baseline data, AVM angioarchitectural features, imaging DICOM data, surgical information, and follow-up information were registered. All patients were evaluated for neurofunction at baseline, 3 months, 12 months, and 3 years after treatment. Main observation endpoints: 1. Modified Rankin Scale; 2. Obliteration rate; 3. Subsequent hemorrhage; 4. Complication rate (such as morbidity rate, new-onset neurological dysfunction, and radiation-related complications). Secondary observation endpoint: improvement of clinical symptoms (epilepsy, headache, neurological dysfunction) at 3 months, 12 months, and 3 years after treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 80
Healthy Volunteers: f
View:

• The diagnosis of AVM was confirmed with digital subtraction angiography (DSA) and/or magnetic resonance imaging(MRI).

• Patients with complete clinical and imaging data.

• Patient or patient's legal representative agreed to collection of information for this study and signed informed consent.

Locations
Other Locations
China
Capital medical university affiliated Beijing Tiantan hospital
RECRUITING
Beijing
Contact Information
Primary
Chen Yu, MD
chenyu_tiantan@126.com
+8618801239327
Backup
Chen Xiaolin, MD
xiaolinchen488@hotmail.com
+8613810624845
Time Frame
Start Date: 2011-08-01
Estimated Completion Date: 2033-04-01
Participants
Target number of participants: 2000
Treatments
experimental group
Ruptured AVMs:~1. AVMs not involved vital eloquent areas, or more than 5 mm away from functional fiber bundles, microsurgery or hybrid surgery can be performed;~2. Targeted embolization for hemorrhagic predictors could be considered as a monotherapy; embolization can be used as an adjunctive strategy to reduce flow or volume before microsurgery or stereotactic radiosurgery (SRS).~3. SRS for patients with a volume less than 10ml and not in the acute phase(\< 3months) of hemorrhage. Volume-stage or dose-stage can be used for giant AVMs involving important eloquent areas.~4. Conservation can be used for AVMs that are prone to severe disability due to intervention.~Unruptured AVMs:~Interventions are recommended if unruptured AVMs are assessed as being at high rupture risk, or have refractory epilepsy or acceptable postoperative neurological deficits, otherwise conservative treatment is recommended. The choice of intervention strategy was the same as for ruptured AVM.
control group
Patients who had not received a multidisciplinary assessment to develop a treatment plan were included in the control group. It should be noted that the multidisciplinary team for AVM was formed in June 2018, so the prospective AVM cohort from August 2011 to June 2018 and the AVM cohort after June 2018 without comprehensive evaluation of treatment regimens by the multidisciplinary team served as the control group.
Sponsors
Collaborators: The General Hospital of Central Theater Command, Hainan People's Hospital, West China Hospital, Second Xiangya Hospital of Central South University, General Hospital of Ningxia Medical University, First Affiliated Hospital of Fujian Medical University, Shengjing Hospital, Binzhou Medical University, Qilu Hospital of Shandong University, Shanxi Provincial People's Hospital, First Affiliated Hospital of Xinjiang Medical University, First Affiliated Hospital of Harbin Medical University, The First Hospital of Jilin University, Second Affiliated Hospital of Soochow University, Shandong Provincial Hospital, Tianjin Medical University Second Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The Second Hospital of Shandong University, Beijing Neurosurgical Institute, Sichuan Provincial People's Hospital, The Affiliated Hospital of Xuzhou Medical University, Jining Medical University, Lanzhou University Second Hospital, The Affiliated Hospital of Qingdao University, The Affiliated Hospital Of Guizhou Medical University, Second Affiliated Hospital of Guangzhou Medical University, First Affiliated Hospital of Chongqing Medical University, The First Affiliated Hospital of Zhengzhou University, Henan Provincial People's Hospital, The Second Affiliated Hospital of Kunming Medical University, First Affiliated Hospital of Zhejiang University, The First Affiliated Hospital of Anhui Medical University, Peking University International Hospital, The First Affiliated Hospital of Shanxi Medical University, First Affiliated Hospital of Guangxi Medical University
Leads: Beijing Tiantan Hospital

This content was sourced from clinicaltrials.gov

Similar Clinical Trials