NCT03919305

Brief Summary

This study was aimed to reveal the clinical features,natural history of the diseases and current therapeutic situations of cerebral venous thrombosis (CVT) in China mainland. Blood samples and cerebrospinal fluid samples will be collected after recruitment to reveal the pathological mechanisms of CVT and identify the biomarkers for CVT.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
38mo left

Started Jun 2019

Longer than P75 for all trials

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress69%
Jun 2019May 2029

First Submitted

Initial submission to the registry

April 3, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 18, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2029

Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

9 years

First QC Date

April 3, 2019

Last Update Submit

April 16, 2019

Conditions

Cerebral Venous Sinus ThrombosisDeep Cerebral Vein ThrombosisCortical Vein Thrombosis

Keywords

Cerebral venous sinus thrombosisDeep cerebral vein thrombosisCortical vein thrombosisCohort studyReal world evidenceObservational studyChina mainlandCerebral venous system thrombosis

Outcome Measures

Primary Outcomes (9)

  • Death rate

    A combination of death form of all causes

    1 year from baseline

  • Functional independence

    Defined as modified Rankin score (0-5) equal to or lower than 2

    1 year from baseline

  • Recurrence of cerebral venous sinus thrombosis, deep cerebral venous thrombosis and cortical vein thrombosis

    Diagnosed by DSA, MRV, CTV or HR-MRI

    1 year from baseline

  • Incidence of hemorrhagic complication

    Extracranial hemorrhage (fall in hemoglobin of 2 gram/dl or more within 48 hours) or intracranial hemorrhage

    1 year from baseline

  • Incidence of sinus wall rupture

    1 year from baseline

  • Incidence of acute ischemic stroke

    1 year from baseline

  • Incidence of acute myocardial infarction

    1 year from baseline

  • Incidence of pulmonary embolism

    1 year from baseline

  • Incidence of deep venous thrombosis

    1 year from baseline

Secondary Outcomes (2)

  • Incidence of epilepsy

    1 year from baseline

  • Incidence of allergic reaction

    1 year from baseline

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with cerebral venous sinus thrombosis, deep cerebral vein thrombosis and cortical vein thrombosis.

You may qualify if:

  • Cerebral venous sinus thrombosis, deep cerebral vein thrombosis and cortical vein thrombosis diagnosed by digital subtraction angiography (DSA), magnetic resonance venography (MRV), computed tomography venography (CTV) or high-resolution magnetic resonance imaging (HR-MRI).

You may not qualify if:

  • None of the patient, trustee or immediate family members signed the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

DNA detection will be conducted in a ramdom selection of 300 blood samples.

Study Officials

  • Xunming Ji, MD, PhD

    Xuanwu Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Li, MD, PhD

CONTACT

+86-18701519698812879698@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 3, 2019

First Posted

April 18, 2019

Study Start

June 1, 2019

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

May 31, 2029

Last Updated

April 18, 2019

Record last verified: 2019-04