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

A Registry Study of Cerebral Venous Sinus Thrombosis in China

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

Study Overview

• Status: Completed
• Conditions: Cerebral Vein Thrombosis; Cerebral Venous Sinus Thrombosis

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 Type: Observational
• Enrollment (Actual): 3276

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100069
      • Xuan Wu Hospital，Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Capital Medical University
• Collaborators: The First Affiliated Hospital of Zhengzhou University; Guizhou Provincial People's Hospital; The Affiliated Hospital of Xuzhou Medical University; Brain Hospital of Hunan Provincial

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2022
• Primary Completion (Actual): December 20, 2023
• Study Completion (Actual): December 20, 2023

Study Registration Dates

• First Submitted: July 2, 2022
• First Submitted That Met QC Criteria: July 2, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Cerebral Venous Sinus Thrombosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Embolism and Thrombosis; Intracranial Thrombosis; Intracranial Embolism and Thrombosis; Thromboembolism; Thrombosis; Sinus Thrombosis, Intracranial
• Other Study ID Numbers: RETAIN-CH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No