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

NCT06583889 | Recruiting DMC

• 1 other identifier: YD2023001
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Cerebral Venous Sinus Thrombosis

Keywords

Cerebral venous sinus thrombosis; Heparin; Randomized controlled trial; Endovascular treatment

Outcome Measures

Primary Outcomes (2)

• Efficacy endpoint

  The proportion of good prognosis (definition: a. mRS≤1; b. headache score (\<50, HIT-6); c. Frisén=0 grade for papilledema; d. defect of field vision PMD\>-2dB)

  90 days (±14 days) after randomization

• Safety endpoint

  New intracranial hemorrhage or aggravation of intracranial hemorrhage after intervention treatment (including: symptomatic hemorrhage and all cerebral hemorrhage found by imaging. Symptomatic intracranial hemorrhage refers to any type of intracranial hemorrhage with NIHSS score increased by 4 points or more, even leading to death) Massive extracranial hemorrhage after intervention treatment (such as obvious clinical symptoms of extracranial organ system hemorrhage such as retroperitoneum, gastrointestinal tract, etc., accompanied by 2g/dl or more decrease in hemoglobin within 48 hours, or the need for infusion of 2 units or more of red blood cells, or the need for surgical intervention or even death)

  Within 7 days after intervention treatment

Secondary Outcomes (11)

• Favorable clinical outcome

  90 days (±14 days) after randomization

• Headache Impact Test-6 (HIT-6)

  90 days (±14 days) after randomization

• Frisén grade for papilledema

  90 days (±14 days) after randomization

• Perimetric Mean Deviation (PMD)

  90 days (±14 days) after randomization

• Required surgical intervention in relation to CVST

  within 90 days

Other Outcomes (10)

• The proportion of good prognosis

  12 months (±1 month) after randomization

• Favorable clinical outcome

  12 months (±1 month) after randomization

• Headache Impact Test-6 (HIT-6)

  12 months (±1 month) after randomization

Study Arms (2)

Standard medical care

ACTIVE COMPARATOR

Drug: Heparin

Endovascular treatment with standard medical care

EXPERIMENTAL

Procedure: Endovascular treatment

Interventions

Heparin DRUG

The patients randomized to standard medical care will receive (or continue) either any type of body-weight adjusted low molecular weight heparin in therapeutic dose, or intravenous adjusted dose unfractionated heparin (aPTT value kept within 1 time the normal value), according to the existing international guidelines.

Standard medical care

Endovascular treatment PROCEDURE

Standard endovascular techniques to mechanically remove clot material, such as mechanical thrombectomy and/or balloon angioplasty and/or local application of alteplase or urokinase within the thrombosed sinuses.

Also known as: Alteplase, Urokinase

Endovascular treatment with standard medical care

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100010, China

RECRUITING

MeSH Terms

Interventions

Heparin; Tissue Plasminogen Activator; Urokinase-Type Plasminogen Activator

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Officials

• Dapeng Mo, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

• Zhongrong Miao, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xu Tong, MD

CONTACT

+8617611338800; dongri0514@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Interventional Neuroradiology, Department of Neurology

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 4, 2024
• Study Start: August 9, 2024
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: September 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)