Clinical Outcome in Patients With Spinal Dural Arteriovenous Fistulas (COPSDAVF)

NCT03192800 | Unknown DMC

• 1 other identifier: COPSDAVF
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal dural arteriovenous fistulas (SDAVFs) are the most common vascular disorder of the spine and account for approximately 70% of spinal vascular malformation.They are a rare pathology with an excepted incidence of only 5-10 new cases per million inhabitants per year. Most fistulas are found in the thoracolumbar region and \> 80% of all SDAVFs are located between T6 and L2, whereas the cranio-cervical, cervical and sacral fistulas are more rare. SDAVFs have an overwhelmingly male predominance (80%), with an age presentation in the fifth or sixth dacede. It is presumed that SDAVFs are acquired diseases. A typical SDAVF is located inside the dural mater close to nerve root. It is fed by a radiculomeningeal artery and enters a radicular vein that merges in the perimedullary plexus. The presence of a shunt leads to a reversal of blood flow to the spinal cord venous system, which then induces venous hypertensive myelopathy.

Conditions

Spinal Vascular Disorder Nos

Keywords

clinical outcome; prognositic factor; spinal dural arteriovenous fistula

Outcome Measures

Primary Outcomes (1)

• Change of the spinal cord function

  Modified Aminoff \& Logue's Scale for evaluating the spinal cord function

  1 day before operation and 3 months, 6 months, 12 months postoperation

Secondary Outcomes (1)

• Modified Denis Pain and Numbness Scale (mDPNS)

  1 day before operation and 3 months, 6 months, 12 months postoperation

Eligibility Criteria

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

Study Population

all patients with spinal dural arteriovenous fistulas admitted to department of neurosurgery in Xuanwu Hospital and department of neurosurgery in Beijing Haidian Hospital.

You may qualify if:

• patient diagnosed with spinal dural arteriovenous fiatulas
• the fiatula locate between C2 and L5
• patient not received surgical or interventional treatment before
• patient with normal cardiac, renal and hepatic function
• patient capable of understanding the content of the patient information / Informed Consent Form
• patient willing and able to participate in the registry

You may not qualify if:

• patient received surgical treatment or interventional treatment before
• patient is pregnant patient allergic to iodine
• patient unable to complete follow-up
• patient with cerebral lesions patient with other spinal lesions
• patient with cardiac, renal or hepatic dysfunction

Sponsors & Collaborators

• Hongqi Zhang, MD: lead
• Beijing Haidian Hospital: collaborator

Study Sites (1)

Neurosurgery Department of Xuanwu hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

Related Publications (6)

• Cenzato M, Versari P, Righi C, Simionato F, Casali C, Giovanelli M. Spinal dural arteriovenous fistulae: analysis of outcome in relation to pretreatment indicators. Neurosurgery. 2004 Oct;55(4):815-22; discussion 822-3. doi: 10.1227/01.neu.0000137630.50959.a7.

  PMID: 15458589 RESULT

• Steinmetz MP, Chow MM, Krishnaney AA, Andrews-Hinders D, Benzel EC, Masaryk TJ, Mayberg MR, Rasmussen PA. Outcome after the treatment of spinal dural arteriovenous fistulae: a contemporary single-institution series and meta-analysis. Neurosurgery. 2004 Jul;55(1):77-87; discussion 87-8. doi: 10.1227/01.neu.0000126878.95006.0f.

  PMID: 15214976 RESULT

• Fugate JE, Lanzino G, Rabinstein AA. Clinical presentation and prognostic factors of spinal dural arteriovenous fistulas: an overview. Neurosurg Focus. 2012 May;32(5):E17. doi: 10.3171/2012.1.FOCUS11376.

  PMID: 22537126 RESULT

• Sherif C, Gruber A, Bavinzski G, Standhardt H, Widhalm G, Gibson D, Richling B, Knosp E. Long-term outcome of a multidisciplinary concept of spinal dural arteriovenous fistulae treatment. Neuroradiology. 2008 Jan;50(1):67-74. doi: 10.1007/s00234-007-0303-4. Epub 2007 Nov 20.

  PMID: 18026943 RESULT

• Saladino A, Atkinson JL, Rabinstein AA, Piepgras DG, Marsh WR, Krauss WE, Kaufmann TJ, Lanzino G. Surgical treatment of spinal dural arteriovenous fistulae: a consecutive series of 154 patients. Neurosurgery. 2010 Nov;67(5):1350-7; discussion 1357-8. doi: 10.1227/NEU.0b013e3181ef2821.

  PMID: 20871454 RESULT

• Krings T, Geibprasert S. Spinal dural arteriovenous fistulas. AJNR Am J Neuroradiol. 2009 Apr;30(4):639-48. doi: 10.3174/ajnr.A1485. Epub 2009 Feb 12.

  PMID: 19213818 RESULT

Study Officials

• Zhang Hongqi, MD.PHD.

  Xuanwu Hospital, Beijing

  STUDY DIRECTOR

Central Study Contacts

Yongjie MA, MD.

CONTACT

+86 15001388570; mayongjiedocotr@sina.com

Hongqi Zhang, PhD. MD.

CONTACT

+86 13601374152; hqzh@vip.163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: June 20, 2017
• Study Start: March 1, 2013
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2025
• Last Updated: April 22, 2021

Record last verified: 2021-04

Locations

CN (1)