Pediatric and Adult Cerebral Arteriovenous Malformation Neurofunctional Outcomes

Cerebral Arteriovenous Malformation Clinical Trial

— DOPA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04593966
• Other study ID #: KY 2019/0917
• Status: Recruiting
• Start date: April 1, 2012
• Est. completion date: December 2024

Study information

• Verified date: October 2020
• Source: Beijing Tiantan Hospital
• Contact: Ruinan Li, MD
• Phone: +8618511287842
• Email: 70akagi[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arteriovenous Malformations
• Cerebral Arteriovenous Malformation
• Congenital Abnormalities
• Hemangioma
• Intracranial Arteriovenous Malformations

Locations

Country	Name	City	State
China	Capital medical university affiliated Beijing Tiantan hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
yuanli Zhao	Peking University International Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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
Primary	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	Obliteration rate	Confirmed by postoperative DSA or MRI/magnetic resonance angiography	At least 1 year, up to 3 years