Multicenter Registry Study Of Cerebral Venous Thrombosis In China (RETAIN-CH)

Completed

• Conditions: Cerebral Vein Thrombosis; Cerebral Venous Sinus Thrombosis

• Registration Number: NCT05448248
• Lead Sponsor: Capital Medical University

Brief Summary

This study will investigate the epidemiology, risk factors, diagnostics, treatment, and the long-term prognosis of cerebral venous thrombosis in China.

Detailed Description

The epidemiology, risk factors, diagnosis and treatment of Cerebral Venous Thrombosis (CVT) in China are still unclear. A retrospective hospital-based study will be conducted at fifty different hospitals across 31 provinces in China. This study will use ICD-10 to search patients diagnosed with CVT between January 1, 2018 and June 15, 2022 across 31 provinces and municipalities of 104 hospitals in China. Risk factors, clinical and radiological findings, treatment and short-term outcomes will be recorded from the hospital record system. Finally, a prospective follow-up will be conducted for all of the patients enrolled above. By combining data collected from retrospective hospital records with the new follow-up, it will be possible to better understand the epidemiology, risk factors, diagnosis, treatment and the long-term prognosis of CVT in China.

Study Timeline

• Study First Submitted: 2022-07-02
• Study First Submitted QC: 2022-07-02
• Study First Posted: 2022-07-07
• Study Start: 2022-08-20
• Primary Completion: 2023-12-20
• Study Completion: 2023-12-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3276

Inclusion Criteria

• 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).

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality	Baseline to three years	A combination of death form of all causes
Favorable clinical outcome (modified Rankin score 0-1)	Baseline to three years

Secondary Outcome Measures

Name	Time	Method
Recurrence of cerebral venous thrombosis	Baseline to three years	Diagnosed by DSA, MRV, CTV or HR-MRI
Recanalization rate of cerebral venous system	Baseline to three years
Incidence of epilepsy	Baseline to three years
Incidence of pulmonary embolism	Baseline to three years
Headache after CVT	Baseline to three years	Headache Impact Test - 6 score
Favorable clinical outcome (modified Rankin score 0-2)	Baseline to three years
Incidence of hemorrhagic complication	Baseline to three years	Extracranial hemorrhage (fall in hemoglobin of 2 gram/dl or more within 48 hours) or intracranial hemorrhage
Psychological distress after CVT	Baseline to three years	Population Health Questionnaire (PHQ)-9 score
Incidence of acute ischemic stroke	Baseline to three years

Trial Locations

Locations (1)

Xuan Wu Hospital，Capital Medical University; 🇨🇳 Beijing, Beijing, China