NCT04593966

Pediatric and Adult Cerebral Arteriovenous Malformation Neurofunctional Outcomes

Differences of Long-term Neurofunctional Outcomes in Pediatric and Adult Eloquent Region Cerebral Arteriovenous Malformation

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: yuanli Zhao · Academic / Other
• Sex: All
• Age: 1 Year – 80 Years
• Healthy volunteers: Not accepted

Summary

Cerebral Arteriovenous malformations (AVMs) are abnormal tangles which are usually believed congenital. AVM can cause different symptoms depending on where it is located, but the most common symptoms are intracranial hemorrhage and seizure. Outcomes of AVM patients can be very different due to factors like the location of lesion, age, sex etc. Generally, more early the intervention was taken, the risk of adverse events would be lower. But the selection of surgical timing for pediatric AVM patients is hard to judge, due to children's cerebral vessels angioarchitecture can be still developing with their age. Some previous studies indicated that there is no difference in intervention outcomes between pediatric and adult AVM patients, so pediatric patients should undergo more aggressive intervention. DOPA study aims to compare the clinical intervention outcomes of both pediatric and adult patients with eloquent region cerebral arteriovenous malformations, helping to determine the treatment strategy.

Detailed description

Follow-up: In the investigators' neurosurgical center, follow-up was conducted for all participants at the first 3-6 months and annually after discharge by clinical visit and telephone interview. Study overview: DOPA will aim on outcomes of both pediatric and adult AVMs patients who underwent intervention in investigators' institution. Intervention strategies contains microsurgical resection, embolization, embolization + radiosurgery, and single-stage hybrid surgery (embolization + resection). Outcomes will be measured by a neurologist using Modified Rankin Scale (mRs). Participants' mRs\<2 will be considered as a good outcome and investigators will keep follow-up with every patient for at least 3 years. Sample size: About 300 patients will be enrolled in this study, and adults and children will account for half. All kinds of intervention will be included. The distribution of different strategies is excepted as: 30% resection, 20% embolization, 30% embolization + radiosurgery and 20% hybrid surgery. Study endpoints: The patients' mRs, occlusion rate and complication will be evaluated at 2 weeks, discharge from hospital, 1 year and 3 years after the first-time intervention.

Conditions

• Cerebral Arteriovenous Malformation

Timeline

• Start date: 2012-04-01
• Primary completion: 2024-11-01
• Completion: 2024-12-01
• First posted: 2020-10-20
• Last updated: 2020-10-20

Locations

1 site across 1 country: China