Endovascular Treatment or Standard Medical Care for Cerebral Venous Sinus Thrombosis(ESCORT)

Last updated: September 2, 2024
Sponsor: Beijing Tiantan Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Thrombosis

Treatment

Endovascular treatment

Heparin

Clinical Study ID

NCT06583889
YD2023001
  • Ages 18-60
  • All Genders

Study 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 better than standard medical care based on the guidelines. Published experience with endovascular treatment is promising. However, its efficacy has not been confirmed and early selection criteria for EVT are unknown.

Objective:The main objective of the Endovascular treatment or Standard medical Care for Cerebral Venous Sinus Thrombosis (ESCORT) trial is to determine if EVT improves the functional outcome of acute and subacute CVST patients with multimodal imaging selection.

Study Design:The ESCORT trial is a multicenter, prospective, randomized, open-label, blinded endpoint trial.

Study population: Patients are eligible if they have a radiologically criteria proven acute and subacute CVST, obvious symptoms of intracranial hypertension(lumbar puncture pressure≥250mmH2O).

Intervention: Patients will be randomized to receive either EVT or standard medical care (therapeutic doses of heparin). EVT consists of local application of alteplase or urokinase within the thrombosed sinuses, balloon angioplasty, and/or mechanical thrombectomy. Glasgow coma score, NIH stroke scale, ophthalmologic examination, Headache Impact Test-6(HIT-6), EuroQol-5 dimension-5 level(EQ-5D-5L) scale score, multimodal imaging and relevant laboratory parameters will be assessed at baseline.

Endpoints: The primary endpoint is the proportion with good prognosis at 3 months (definition: a. mRS≤1; b. headache score (<50, HIT-6); c. Frisén=0 grade for papilledema; d. defect of field vision PMD>-2dB). Secondary outcomes are three-months mRS, HIT-6,Frisén grade for papilledema, situation of EQ-5D-5L, mortality and recanalization rate. Major intracranial and extracranial hemorrhagic complications within one-week after the intervention are the principal safety outcomes. Results will be analyzed according to the'intention-to-treat' principle. Blinded assessors not involved in the treatment of the patient will assess endpoints with standardized questionnaires.

Study size: To detect a 20% relative increase of good prognosis (from 65 to 85%), 224 patients (112 in each treatment arm) have to be included (two-sided alpha, 80% power).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Included patients may benefit directly from EVT. Complications of EVT, most notably intracranial hemorrhages, constitute the most important risk of the study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

General inclusion criteria

  1. age between 18 years and 60 years

  2. Cerebral venous sinus thrombosis (CVST), confirmed by computed tomographic andmagnetic 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 acuteonset (2) There are one of the obvious clinical symptoms: A. symptoms ofintracranial hypertension: headache, papilledema, visual acuity and visual fielddamage; B. Neurological impairment symptoms; C. Seizure; D. Disturbance ofconsciousness (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 thecorresponding sigmoid sinus involvement

  2. complete thrombosis of the superior transverse sinus with or without thecorresponding sigmoid sinus involvement C.complete thrombosis of the superiorsagittal sinus and unilateral transverse sinus with or without the correspondingsigmoid sinus involvement D.complete thrombosis of the superior sagittal sinus andbilateral transverse sinus with the corresponding sigmoid sinus is occluded

Exclusion

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 completeneurological function assessment and follow-up

  4. Patients with high myopia and eye diseases affecting fundus examination and visualfield examination

  5. The patient has a clear history of primary headache such as migraine, tensionheadache and cluster headache, and a clear history of secondary headache

  6. Patients who receive major surgery (excluding lumbar puncture) or a history ofsevere 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 rectoanal hemorrhoids)

  9. Serious liver function or renal dysfunction with written records and affectingnormal 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 asadvanced 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 primarythrombocytosis, 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 tomassive cerebral edema, cerebral infarction or cerebral hemorrhage

  19. Patients with CVST accompanied by ventricular compression and hydrocephalusrequiring surgery

  20. Participating in clinical trials of any other drugs or medical devices, or mayparticipate in clinical trials of any other drugs or medical devices within 6 monthsafter being enrolled in this clinical trial

  21. The researchers judge that there are other situations that are not suitable forenrollment

Study Design

Total Participants: 224
Treatment Group(s): 2
Primary Treatment: Endovascular treatment
Phase:
Study Start date:
August 09, 2024
Estimated Completion Date:
August 31, 2029

Connect with a study center

  • Beijing Tiantan Hospital

    Beijing, Beijing 100010
    China

    Site Not Available

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