NCT03273179

Brief Summary

This is a single-center, retrospective, open-label study. This study is planned to investigate the accuracy of mRS and NIHSS, comparing with the accuracy of CSF pressure and papilledema grade in assessing cerebral venous sinus thrombosis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

February 5, 2018

Status Verified

February 1, 2018

Enrollment Period

10 months

First QC Date

September 3, 2017

Last Update Submit

February 2, 2018

Conditions

Cerebral Venous Sinus ThrombosisCSF Pressure IncreasedPapilledema

Keywords

cerebral venous sinus thrombosisCSF pressuremodified Rankin ScalepapilledemaNIHSS

Outcome Measures

Primary Outcomes (3)

  • baseline CSF pressure

    CSF pressure at baseline

    baseline

  • baseline mRS

    mRS at baseline

    baseline

  • baseline papilledema grade

    Frisen grade of papilledema at baseline

    baseline

Secondary Outcomes (1)

  • baseline NIHSS

    baseline

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All individual with confirmed diagnosis of CVST are eligible for this research

You may qualify if:

  • confirmed diagnosis of CVST by head MRI, DSA or MRV onset of CVST within one month

You may not qualify if:

  • unable to complete examinations unable to complete follow-ups

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Intracranial HypertensionPapilledema

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesOptic Nerve DiseasesCranial Nerve DiseasesEye Diseases

Central Study Contacts

Xunming Ji

CONTACT

+86-83198952jixunming@vip.163.com

Zhen Zhang

CONTACT

gzhenzhang@sina.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 3, 2017

First Posted

September 6, 2017

Study Start

June 1, 2017

Primary Completion

April 1, 2018

Study Completion

July 1, 2018

Last Updated

February 5, 2018

Record last verified: 2018-02

Locations

CN(1)