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

Cerebral Vein Thrombosis Clinical Trial

Official title:

A Registry Study of Cerebral Venous Sinus Thrombosis in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05448248
• Other study ID #: RETAIN-CH
• Status: Completed
• Start date: August 20, 2022
• Est. completion date: December 20, 2023

Study information

• Verified date: February 2024
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3276
• Est. completion date: December 20, 2023
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Vein Thrombosis
• Cerebral Venous Sinus Thrombosis
• Sinus Thrombosis, Intracranial
• Thrombosis

Locations

Country	Name	City	State
China	Xuan Wu Hospital,Capital Medical University	Beijing	Beijing

Sponsors (5)

Lead Sponsor	Collaborator
Capital Medical University	Brain Hospital of Hunan Provincial, Guizhou Provincial People's Hospital, The Affiliated Hospital of Xuzhou Medical University, The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Favorable clinical outcome (modified Rankin score 0-1)		Baseline to three years
Primary	All-cause mortality	A combination of death form of all causes	Baseline to three years
Secondary	Recurrence of cerebral venous thrombosis	Diagnosed by DSA, MRV, CTV or HR-MRI	Baseline to three years
Secondary	Favorable clinical outcome (modified Rankin score 0-2)		Baseline to three years
Secondary	Headache after CVT	Headache Impact Test - 6 score	Baseline to three years
Secondary	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
Secondary	Recanalization rate of cerebral venous system		Baseline to three years
Secondary	Incidence of epilepsy		Baseline to three years
Secondary	Incidence of acute ischemic stroke		Baseline to three years
Secondary	Incidence of pulmonary embolism		Baseline to three years
Secondary	Psychological distress after CVT	Population Health Questionnaire (PHQ)-9 score	Baseline to three years