Cerebral Venous Sinus Thrombosis: Re-exploration of Clini... | NCT03273179

Studies
Cerebral Venous Sinus Thrombosis: Re-exploration of Clinical Assessment Scales

NCT03273179

Sponsor

Capital Medical University

Status

Unknown status

Last Update Posted

Feb 5, 2018Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Cerebral Venous Sinus Thrombosis
CSF Pressure Increased
Papilledema

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2017Actual

Primary Completion Date

Apr 1, 2018Estimated

Completion Date

Jul 1, 2018Estimated

First Submitted Date

Sep 3, 2017

First Submission Date that Met QC Criteria

Sep 3, 2017

First Posted Date

Sep 6, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2018

Last Update Posted Date

Feb 5, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
baseline NIHSS	NIH Stroke Scale at baseline	baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

unable to complete examinations unable to complete follow-ups

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xunming Ji	Contact	+86-83198952		jixunming@vip.163.com
Zhen Zhang	Contact			gzhenzhang@sina.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xuanwu Hospital Capital Medical University	Recruiting	Beijing			China

Condition Browse Module

MeSH Terms

ID	Term
D019586	Intracranial Hypertension
D010211	Papilledema

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D009901	Optic Nerve Diseases

Browse Leaves

Not provided

Browse Branches

Not provided