Cerebral Venous Sinus ThrombosisESCORTNCT06583889
Endovascular Treatment or Standard Medical Care for Cerebral Venous Sinus Thrombosis(ESCORT)
A study testing Heparin and Endovascular treatment in people with Cerebral Venous Sinus Thrombosis, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cerebral Venous Sinus Thrombosis
- What is being tested?
- Heparin and Endovascular treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2024to Aug 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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:
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of endovasCular Treatment vs Standard Medical Care for Cerebral venOus Sinus thRombosis With mulTimodal Imaging Selection(ESCORT)
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.
Read more
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
- Being tested
- Heparin, Endovascular treatment
- Keywords
- Cerebral venous sinus thrombosis, Heparin, Randomized controlled trial, Endovascular treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeparinDrug
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.
Endovascular treatmentProcedure or surgery
Also called Alteplase, Urokinase
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard medical care | Active comparator | Not described Receives: Drug: Heparin |
| Endovascular treatment with standard medical care | Experimental | Not described Receives: Procedure: Endovascular treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: Within 7 days after intervention treatment
Secondary outcomes (11)
Favorable clinical outcome
mRS≤1
Measured: 90 days (±14 days) after randomization
Headache Impact Test-6 (HIT-6)
HIT-6 score<50
Measured: 90 days (±14 days) after randomization
Frisén grade for papilledema
The Frisén=0 grade
Measured: 90 days (±14 days) after randomization
Perimetric Mean Deviation (PMD)
The perimetric mean deviation(PMD)>-2dB of visual field defect
Measured: 90 days (±14 days) after randomization
Required surgical intervention in relation to CVST
The proportion of surgical intervention within 90 days after randomization that are required in relation to cerebral venous thrombosis (e.g. ventricular shunting procedures or craniotomy)
Measured: within 90 days
Recanalization rate of cerebral venous sinus
The proportion of complete and partial recanalization of venous sinus (according to Qureshi classification criteria)
Measured: 90 days (±14 days) after randomization
EuroQol-5 dimension-5 level(EQ-5D-5L) scale score
Measured: 90 days (±14 days) after randomization
All-cause mortality
Measured: 90 days after randomization
The incidence of cerebral hernia
Measured: 90 days after randomization
The proportion of decompressive craniectomy
Measured: 90 days after randomization
The incidence of other serious adverse events
Measured: 90 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start24 Dec 2024
- Primary completionJan 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Venous Sinus ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dapeng Mo, Beijing Tiantan Hospital
- Investigators
- Dapeng Mo, MD, Principal investigator, Beijing Tiantan HospitalZhongrong Miao, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583889
- Sponsor's protocol ID
- YD2023001
- Acronym
- ESCORT
- Status last verified
- Aug 2026
- First submitted
- 2 Sep 2024
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No