Comparing endovascular treatment to standard care for cerebral venous sinus thrombosis

Efficacy and Safety of endovasCular Treatment vs Standard Medical Care for Cerebral venOus Sinus thRombosis With mulTimodal Imaging Selection(ESCORT)

This study is testing if a new procedure called endovascular treatment can help people with a specific type of blood clot in the brain feel better compared to standard medical care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 224 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06583889 on ClinicalTrials.gov

What this trial studies

The ESCORT trial aims to evaluate whether endovascular treatment (EVT) can improve functional outcomes in patients with acute and subacute cerebral venous sinus thrombosis (CVST) compared to standard medical care. This multicenter, prospective, randomized, open-label trial will enroll patients who meet specific radiological and clinical criteria, including symptoms of intracranial hypertension. Participants will be selected based on multimodal imaging techniques, and the study will assess the efficacy of EVT in this population. The trial seeks to clarify the effectiveness of EVT, which has shown promise in previous experiences but lacks extensive validation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 60 with confirmed acute or subacute CVST and symptoms of intracranial hypertension.

Not a fit: Patients outside the age range of 18 to 60 or those without confirmed CVST may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from cerebral venous sinus thrombosis.

How similar studies have performed: While previous studies have shown promising results for endovascular treatment in CVST, this specific approach has not been extensively validated in diverse populations.

Eligibility criteria

Inclusion Criteria:

General inclusion criteria

1. age between 18 years and 60 years
2. 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.
3. 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)
4. Lumbar puncture pressure≥250mmH2O
5. Patients or their relatives can sign written informed consent

Image inclusion criteria

1.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:

1. complete thrombosis of the bilateral transverse sinus with or without the corresponding sigmoid sinus involvement
2. 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 Criteria:

1. Received any thrombolytic therapy within 7 days
2. Patients who cannot cooperate or accept MRI examination
3. Patients with dementia or mental illness are known to be unable to complete neurological function assessment and follow-up
4. Patients with high myopia and eye diseases affecting fundus examination and visual field examination
5. The patient has a clear history of primary headache such as migraine, tension headache and cluster headache, and a clear history of secondary headache
6. Patients who receive major surgery (excluding lumbar puncture) or a history of severe brain injury within 2 weeks
7. Known history of severe allergy to contrast media (excluding rash)
8. Gastrointestinal bleeding occurred within 3 months (excluding bleeding from recto anal hemorrhoids)
9. Serious liver function or renal dysfunction with written records and affecting normal coagulation function
10. Hemorrhagic disease (hemorrhagic disease history) with written records
11. Excepting for CVST, patients with any life expectancy less than 1 year (such as advanced cancer)
12. Pregnant women (puerperal women can be enrolled)
13. Patients with contraindications to anticoagulation or thrombolysis
14. Intracranial infectious or malignant tumor secondary to cerebrospinal fluid
15. CVST secondary to autoimmune diseases and hematological diseases (such as primary thrombocytosis, myelodysplastic syndrome, leukemia, etc.) and genetic factors
16. Concurrent thrombocytopenia (\<100×109/L)
17. MRI features showed that the occluded vessels of venous sinus were in chronic phase (T1 and T2 images showed equal signal)
18. Severe brain tissue injury symptoms such as obvious space occupying effect due to massive cerebral edema, cerebral infarction or cerebral hemorrhage
19. Patients with CVST accompanied by ventricular compression and hydrocephalus requiring surgery
20. 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
21. The researchers judge that there are other situations that are not suitable for enrollment

Where this trial is running

Beijing, Beijing Municipality

• Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Dapeng Mo, MD — Beijing Tiantan Hospital
• Study coordinator: Xu Tong, MD

Conditions Cerebral Venous Sinus Thrombosis; Cerebral venous sinus thrombosis; Heparin; Randomized controlled trial; Endovascular treatment