Pediatric and Adult Cerebral Arteriovenous Malformation Neurofunctional Outcomes

NCT04593966 | Unknown

• 1 other identifier: KY 2019/0917
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Arteriovenous Malformation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Obliteration rate

  At least 1 year, up to 3 years

Study Arms (2)

Pediatric AVM

1. AVM patients' age under 18-years-old who underwent intervention in investigators' institution. 2. Patients' lesions were located in eloquent and confirmed by image.

Adult AVM

1. AVM patients' age over 18-years-old who underwent intervention in investigators' institution. 2. Patients' lesions were located in eloquent and confirmed by image.

Eligibility Criteria

• Age: 1 Year - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with brain arteriovenous malformation which located in eloquent area.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• yuanli Zhao: lead
• Peking University International Hospital: collaborator

Study Sites (1)

Capital medical university affiliated Beijing Tiantan hospital

Beijing, Beijing Municipality, 101100, China

RECRUITING

MeSH Terms

Conditions

Intracranial Arteriovenous Malformations

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Central Nervous System Vascular Malformations; Nervous System Malformations; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Intracranial Arterial Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Ruinan Li, MD

CONTACT

+8618511287842; 70akagi@gmail.com

Yuanli Zhao, MD

CONTACT

+8601069006284; zhaoyuanli@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chairman of Neurosurgical center

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: October 20, 2020
• Study Start: April 1, 2012
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 20, 2020

Record last verified: 2020-10

Locations

CN (1)