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Steroid for Treatment of Acute/Subacute Severe Cerebral Venous Thrombosis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05990894
Recruitment Status : Completed
First Posted : August 14, 2023
Last Update Posted : August 15, 2023
Sponsor:
Information provided by (Responsible Party):
JiangangDuan, Xuanwu Hospital, Beijing

Study Description
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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.

Condition or disease Intervention/treatment
Cerebral Venous Thrombosis Drug: Methylprednisolone

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.

Study Design
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Study Type : Observational
Actual Enrollment : 248 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy and Safety of Steroid for Treatment of Acute/Subacute Severe Cerebral Venous Thrombosis.
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : December 31, 2021
Actual Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Standard treatment group
Each patient received subcutaneous low-molecular-weight heparin in adjusted doses for 10 to 14 days, followed by oral anticoagulants (warfarin or dabigatran or rivaroxaban, if warfarin was used, PT-INR was maintained between 2.0 and 3.0) for 6 months or more. The use of endovascular treatment (local thrombectomy/thrombolysis) was reserved for patients who are still progressing with adequate anticoagulant therapy.
Steroid therapy group
Patients in the steroid therapy group received short-term steroids in addition to standard anticoagulant therapy.
 Drug: Methylprednisolone
In the steroid therapy group, patients received standard treatment plus steroid therapy. Steroid therapy protocol is as follows: 500 mg methylprednisolone once a day, intravenous drip for 3 days, then reduced to 80 mg once a day, intravenous drip for 5 days, and changed to oral methylprednisolone/prednisone 1 mg per kilogram body weight, gradually tapered off by a dose of 10 mg per week.


Outcome Measures
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Primary Outcome Measures :
  1. modified Rankin score(mRS) [ Time Frame: 6 months after discharge ]
    mRS score >2 indicates poor prognosis and mRS score ≤2 indicates favorable outcome.


Secondary Outcome Measures :
  1. Recurrence of CVT [ Time Frame: 6 months after discharge ]
    Diagnosed by MRI/MRBTI/MRV, CTV, or DSA.

  2. Serious steroids complications [ Time Frame: 6 months after discharge ]
    1. Lower extremity deep venous thrombosis.
    2. Pulmonary embolism
    3. Spontaneous fractures or osteonecrosis
    4. Infection
    5. gastroduodenal ulcer


Other Outcome Measures:
  1. Residual symptoms [ Time Frame: 6 months after discharge ]
    Including headaches, visual disturbances, epilepsy, and current work status.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with first-episode acute/subacute CVT were enrolled in a prospective stroke registry at Xuanwu Hospital, Capital Medical University, from January 2018 to June 2021.
Criteria

Inclusion Criteria:

  • Acute (within 7 days after symptom onset) or subacute (8-15 days since symptom onset) severe CVT diagnosed by MRI+MRV, CT+CTV, or DSA.

Exclusion Criteria:

  • Patients with malignancies
  • Patients with incomplete follow-up data.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05990894


Locations
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China
Xuanwu Hospital, Capital Medical University
Beijing, China
Sponsors and Collaborators
Xuanwu Hospital, Beijing
Investigators
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Principal Investigator: Jiangang Duan, MD, PhD Xuanwu Hospital, Beijing
More Information
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Responsible Party: JiangangDuan, MD, PhD, Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT05990894    
Other Study ID Numbers: [2020]098
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: August 15, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by JiangangDuan, Xuanwu Hospital, Beijing:
Cerebral venous thrombosis
Severe cerebral venous thrombosis
Steroid therapy
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
 Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents