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Pediatric and Adult Cerebral Arteriovenous Malformation Neurofunctional Outcomes (DOPA)

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ClinicalTrials.gov Identifier: NCT04593966
Recruitment Status : Recruiting
First Posted : October 20, 2020
Last Update Posted : October 20, 2020
Sponsor:
Collaborator:
Peking University International Hospital
Information provided by (Responsible Party):
yuanli Zhao, Beijing Tiantan Hospital

Study Description
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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.

Condition or disease
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 Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Differences of Long-term Neurofunctional Outcomes in Pediatric and Adult Eloquent Region Cerebral Arteriovenous Malformation
Actual Study Start Date : April 1, 2012
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. modified Ranking Scale score at 2 weeks after the operation [ Time Frame: 2 weeks ]

    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. modified Ranking Scale score when discharge [ Time Frame: Discharge (assessed up to 10 days) ]

    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. modified Ranking Scale score at 1 years after the operation [ Time Frame: 1 years ]

    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


  4. modified Ranking Scale score at 3 years after the operation [ Time Frame: 3 years ]

    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



Secondary Outcome Measures :
  1. Obliteration rate [ Time Frame: At least 1 year, up to 3 years ]
    Confirmed by postoperative DSA or MRI/magnetic resonance angiography


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with brain arteriovenous malformation which located in eloquent area.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04593966


Contacts
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Contact: Ruinan Li, MD +8618511287842 70akagi@gmail.com
Contact: Yuanli Zhao, MD +8601069006284 zhaoyuanli@126.com

Locations
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China, Beijing
Capital medical university affiliated Beijing Tiantan hospital Recruiting
Beijing, Beijing, China, 101100
Contact: Ruinan Li, MD    +8618511287842    70akagi@gmail.com   
Sponsors and Collaborators
yuanli Zhao
Peking University International Hospital
More Information
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Responsible Party: yuanli Zhao, Chairman of Neurosurgical center, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT04593966    
Other Study ID Numbers: KY 2019/0917
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemangioma
Intracranial Arteriovenous Malformations
Arteriovenous Malformations
Congenital Abnormalities
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases
Neoplasms, Vascular Tissue
 Neoplasms by Histologic Type
Neoplasms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Vascular Malformations
Nervous System Malformations
Intracranial Arterial Diseases