Status:
RECRUITING
Endovascular Treatment or Standard Medical Care for Cerebral Venous Sinus Thrombosis(ESCORT)
Lead Sponsor:
Beijing Tiantan Hospital
Conditions:
Cerebral Venous Sinus Thrombosis
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Background: It has not been extensively studied in differing populations that endovascular treatment (EVT) for acute and subacute CVST with multimodal imaging selection improves the functional outcome...
Eligibility Criteria
Inclusion
- General inclusion criteria
- age between 18 years and 60 years
- Cerebral venous sinus thrombosis (CVST), confirmed by computed tomographic and magnetic resonance imaging (T1, T2, SWI, DWI, FLAIR), magnetic resonance venography, computed tomographic venography or digital subtraction angiography.
- Patients with CVST who meet the following conditions (1) Within 3 weeks of acute onset (2) There are one of the obvious clinical symptoms: A. symptoms of intracranial hypertension: headache, papilledema, visual acuity and visual field damage; B. Neurological impairment symptoms; C. Seizure; D. Disturbance of consciousness (GCS score≥9)
- Lumbar puncture pressure≥250mmH2O
- Patients or their relatives can sign written informed consent
- Image inclusion criteria
- CT and MRI (T1, T2, MRV, SWI, DWI) are used to screen CVST as acute phase (T1 low signal, T2 equal signal or slightly high signal; CT showed that the corresponding area is high signal) or subacute phase (T1 and T2 high signal) 2.3D-TOF or CE-MRA or CTV are used to screen the types of venous sinus thrombosis occlusion of main drainage which is prone to intracranial hypertension due to venous sinus thrombosis as follows: A.Superior sagittal sinus occlusion: thrombus obliterates the posterior 1/2 segment of superior sagittal sinus
- B.Transverse sinus occlusive type:
- complete thrombosis of the bilateral transverse sinus with or without the corresponding sigmoid sinus involvement
- complete thrombosis of the superior transverse sinus with or without the corresponding sigmoid sinus involvement C.complete thrombosis of the superior sagittal sinus and unilateral transverse sinus with or without the corresponding sigmoid sinus involvement D.complete thrombosis of the superior sagittal sinus and bilateral transverse sinus with the corresponding sigmoid sinus is occluded
Exclusion
- Received any thrombolytic therapy within 7 days
- Patients who cannot cooperate or accept MRI examination
- Patients with dementia or mental illness are known to be unable to complete neurological function assessment and follow-up
- Patients with high myopia and eye diseases affecting fundus examination and visual field examination
- The patient has a clear history of primary headache such as migraine, tension headache and cluster headache, and a clear history of secondary headache
- Patients who receive major surgery (excluding lumbar puncture) or a history of severe brain injury within 2 weeks
- Known history of severe allergy to contrast media (excluding rash)
- Gastrointestinal bleeding occurred within 3 months (excluding bleeding from recto anal hemorrhoids)
- Serious liver function or renal dysfunction with written records and affecting normal coagulation function
- Hemorrhagic disease (hemorrhagic disease history) with written records
- Excepting for CVST, patients with any life expectancy less than 1 year (such as advanced cancer)
- Pregnant women (puerperal women can be enrolled)
- Patients with contraindications to anticoagulation or thrombolysis
- Intracranial infectious or malignant tumor secondary to cerebrospinal fluid
- CVST secondary to autoimmune diseases and hematological diseases (such as primary thrombocytosis, myelodysplastic syndrome, leukemia, etc.) and genetic factors
- Concurrent thrombocytopenia (\<100×109/L)
- MRI features showed that the occluded vessels of venous sinus were in chronic phase (T1 and T2 images showed equal signal)
- Severe brain tissue injury symptoms such as obvious space occupying effect due to massive cerebral edema, cerebral infarction or cerebral hemorrhage
- Patients with CVST accompanied by ventricular compression and hydrocephalus requiring surgery
- Participating in clinical trials of any other drugs or medical devices, or may participate in clinical trials of any other drugs or medical devices within 6 months after being enrolled in this clinical trial
- The researchers judge that there are other situations that are not suitable for enrollment
Key Trial Info
Start Date :
August 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2029
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT06583889
Start Date
August 9 2024
End Date
August 1 2029
Last Update
September 4 2024
Active Locations (1)
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1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100010