Pediatric and Adult Cerebral Arteriovenous Malformation Neurofunctional Outcomes (DOPA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Arteriovenous Malformation

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Ruinan Li, MD; Phone Number: +8618511287842; Email: 70akagi@gmail.com
• Study Contact Backup: Name: Yuanli Zhao, MD; Phone Number: +8601069006284; Email: zhaoyuanli@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 101100
      • Recruiting
      • Capital Medical University Affiliated Beijing Tiantan Hospital
      • Contact: Ruinan Li, MD; Phone Number: +8618511287842; Email: 70akagi@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 80 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with brain arteriovenous malformation which located in eloquent area.

Description

Inclusion Criteria:

• The diagnosis of AVM was confirmed with digital subtraction angiography (DSA) and/or magnetic resonance imaging(MRI).
• Patients had underwent interventions in our institution.
• AVMs were located in eloquent area.

Exclusion Criteria:

• Patients with multiple AVMs.
• Patients with hereditary hemorrhagic telangiectasia (HHT).
• Patients with missing clinical and imaging data.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Pediatric AVM; AVM patients' age under 18-years-old who underwent intervention in investigators' institution.; Patients' lesions were located in eloquent and confirmed by image.
Adult AVM; AVM patients' age over 18-years-old who underwent intervention in investigators' institution.; Patients' lesions were located in eloquent and confirmed by image.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
modified Ranking Scale score at 2 weeks after the operation	The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. No significant disability. Able to carry out all usual activities, despite some symptoms. Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Moderate disability. Requires some help, but able to walk unassisted. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Dead	2 weeks
modified Ranking Scale score when discharge	The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. No significant disability. Able to carry out all usual activities, despite some symptoms. Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Moderate disability. Requires some help, but able to walk unassisted. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Dead	Discharge (assessed up to 10 days)
modified Ranking Scale score at 1 years after the operation	The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. No significant disability. Able to carry out all usual activities, despite some symptoms. Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Moderate disability. Requires some help, but able to walk unassisted. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Dead	1 years
modified Ranking Scale score at 3 years after the operation	The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. No significant disability. Able to carry out all usual activities, despite some symptoms. Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Moderate disability. Requires some help, but able to walk unassisted. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Dead	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Obliteration rate	Confirmed by postoperative DSA or MRI/magnetic resonance angiography	At least 1 year, up to 3 years

Collaborators and Investigators

• Sponsor: yuanli Zhao
• Collaborators: Peking University International Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2012
• Primary Completion (ANTICIPATED): November 1, 2024
• Study Completion (ANTICIPATED): December 1, 2024

Study Registration Dates

• First Submitted: September 10, 2020
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (ACTUAL): October 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 20, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Cardiovascular Abnormalities; Neoplasms, Vascular Tissue; Nervous System Malformations; Vascular Malformations; Intracranial Arterial Diseases; Central Nervous System Vascular Malformations; Congenital Abnormalities; Hemangioma; Arteriovenous Malformations; Intracranial Arteriovenous Malformations
• Other Study ID Numbers: KY 2019/0917

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No