Clinical trial NCT05990894: Steroid for Treatment of Acute/Subacute Severe Cerebral Venous Thrombosis.
Official title: Efficacy and Safety of Steroid for Treatment of Acute/Subacute Severe Cerebral Venous Thrombosis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Venous Thrombosis
Keywords: Cerebral venous thrombosis
Severe cerebral venous thrombosis
Steroid therapy
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 170
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with acute/subacute severe CVT were enrolled in a prospective cohort at Xuanwu Hospital, Capital Medical University, between July 2020 and January 2024.

Brief summary: The cohort study aims to evaluate the efficacy and safety of steroids combined with anticoagulant therapy compared to standard anticoagulant therapy in acute/subacute severe cerebral venous thrombosis.

Detailed description: Background: Evidence suggests that the inflammatory response plays a crucial role in regulating severe CVT pathogenesis. However, whether CVT patients can benefit from anti-inflammatory therapy has been debated.

Objective: The objective of this cohort study is to explore the efficacy and safety of steroids combined with anticoagulant therapy compared to standard anticoagulant therapy in acute/subacute severe cerebral venous thrombosis (CVT) patients.

Method: We reviewed the data of patients with acute/subacute severe CVT treated with a short-term application of steroid or not from a prospective stroke registry of our center. We compared functional outcomes and major adverse events at 6 months follow-up after discharge.

Eligibility criteria: Inclusion Criteria:

* Acute or subacute severe CVT, determined by the onset-to-admission time (≤ 15 days) or symptom aggravation-to-admission time (≤ 15 days) and MRI+MRV/MRBTI (MR Black-Blood Thrombus Imaging), or CT+CTV

Exclusion Criteria:

* younger than 14 years；
* foreign nationality；
* receiving steroids before the onset of CVT；
* patients with other serious diseases；
* Presenting with neurological deficits before the onset of CVT；
* lack of baseline data before treatment；
* receiving steroids during hospitalization for other reasons but the dosage did not reach pulsed-therapy level
* brain herniation but refusing to undergo decompressive craniectomy, or pupillary light reflex did not recover after decompressive craniectomy

Primary outcomes:
measure: favorable functional outcome.
timeFrame: 6 months after discharge
Secondary outcomes:
measure: Serious steroid complications during hospitalization
timeFrame: from admission to discharge (up to 4 weeks after admission)
measure: Serious steroids complications within 6 months after discharge
timeFrame: 6 months after discharge
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Jiangang Duan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: