Actively Recruiting
Efficacy and Safety of Endovascular Treatment vs Standard Medical Care for Cerebral Venous Sinus Thrombosis With Multimodal Imaging Selection (ESCORT)
Led by Beijing Tiantan Hospital · Updated on 2024-09-04
224
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether endovascular treatment (EVT) improves the functional outcomes of patients with acute and subacute cerebral venous sinus thrombosis (CVST) who are selected using multimodal imaging. This trial compares EVT to standard medical care with therapeutic heparin doses. The study is a multicenter, prospective, randomized, open-label trial with blinded assessment of outcomes. The rationale includes promising but unconfirmed benefits of EVT and unknown early selection criteria for this treatment. Participants are randomly assigned to receive either standard medical care with heparin or EVT, which involves mechanical removal of clot material by techniques such as mechanical thrombectomy, balloon angioplasty, or local application of clot-dissolving drugs like alteplase or urokinase. The treatment is delivered locally within the thrombosed sinuses. The trial includes imaging selection criteria and clinical symptom assessment at baseline to determine eligibility. During the study, participants undergo assessments including the Glasgow coma score, NIH stroke scale, eye examinations for papilledema, headache impact tests, quality of life scales (EQ-5D-5L), and multimodal imaging. The primary outcome is a good prognosis at 3 months based on functional and symptom scores, while safety outcomes focus on hemorrhagic complications within one week post-intervention. Secondary outcomes include mortality, recanalization rates, and detailed neurological and quality of life measures. The study duration includes follow-up visits up to 3 months after randomization with blinded endpoint evaluation.
CONDITIONS
Brief Title
Endovascular Treatment or Standard Medical Care for Cerebral Venous Sinus Thrombosis(ESCORT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 years and 60 years
- Confirmed cerebral venous sinus thrombosis by CT, MRI, MR venography, CT venography, or digital subtraction angiography
- Acute or subacute CVST within 3 weeks of onset with clinical symptoms such as intracranial hypertension, neurological impairment, seizure, or consciousness disturbance (GCS score ≥9)
- Lumbar puncture pressure ≥250 mmH2O
- Ability of patient or relatives to provide written informed consent
- Imaging showing specific types of venous sinus thrombosis occlusion prone to intracranial hypertension
You will not qualify if you...
- Received any thrombolytic therapy within 7 days prior
- Unable to cooperate with or accept MRI examination
- Dementia or mental illness preventing neurological assessment and follow-up
- High myopia or eye diseases affecting fundus and visual field examination
- History of primary or secondary headaches such as migraine, tension, or cluster headaches
- Major surgery or severe brain injury within 2 weeks (excluding lumbar puncture)
- Severe allergy to contrast media (except rash)
- Gastrointestinal bleeding within 3 months (excluding hemorrhoids)
- Serious liver or kidney dysfunction affecting coagulation
- Hemorrhagic disease history
- Life expectancy less than 1 year except CVST
- Pregnant women (puerperal women allowed)
- Contraindications to anticoagulation or thrombolysis
- Intracranial infection or malignant tumor secondary to cerebrospinal fluid
- CVST secondary to autoimmune, hematological, or genetic diseases
- Thrombocytopenia (platelet count <100x10^9/L)
- MRI features showing chronic phase occlusion
- Severe brain injury with mass effect due to edema, infarction, or hemorrhage
- CVST with ventricular compression and hydrocephalus requiring surgery
- Participation in other drug or device clinical trials within 6 months
- Other reasons judged by researchers as unsuitable for enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 7 days after intervention treatment
Participants receive either standard medical care with anticoagulant drugs or endovascular treatment combined with standard medical care.
1 to 2 visits depending on treatment assignment
Duration - Up to 90 days (±14 days) after randomization
Participants are monitored for efficacy and safety outcomes after treatment.
1 visit around 90 days after treatment
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100010
Actively Recruiting
Research Team
X
Xu Tong, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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