Status:
UNKNOWN
Efficacy and Safety of Rivaroxaban in the Prevention of Venous Thromboembolism in Glioma Patients
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Conditions:
Glioma, Malignant
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Glioma is a common brain tumor with a high risk of venous thromboembolism during treatment, especially in the months after surgery. Postoperative lower extremity dyskinesia in patients with gliomas is...
Detailed Description
Venous thromboembolism (VTE) is a disorder in which blood clots abnormally in the veins, resulting in complete or incomplete blockage of blood vessels, including deep vein thrombosis and pulmonary emb...
Eligibility Criteria
Inclusion
- Individuals aged 18-80 years old with highly suspected (as assessed by study surgeon), newly diagnosed, untreated glioma.
- Patients without heart insufficiency, lungs insufficiency, renal insufficiency, hepatic insufficiency, autoimmune diseases and other organ diseases with severe dysfunction.
- Individuals who agree to undergo surgical resection.
- Individuals with dyskinesia after surgery.
- All patients giving written informed consent.
Exclusion
- Individuals with age \< 18 years or \> 80 years.
- Patients with heart insufficiency, lungs insufficiency, renal insufficiency, hepatic insufficiency, autoimmune diseases and other organ diseases with severe dysfunction.
- Individuals have acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea), have peptic ulcer and gastrointestinal bleeding in the past 5 years.
- Patients have history of long-term (current) use of anticoagulants, spontaneous intracranial hemorrhage, and venous thromboembolism.
- Individuals have intracranial hemorrhage after surgery, or other active bleeding.
- Postoperative coagulation disorders (INR \>1.5 or platelet counts \< 100x10\^9/L).
- Patients are allergic to Rivaroxaban.
- Pregnancy or breast-feeding women.
- Inability to give written informed consent.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2025
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT06196918
Start Date
November 1 2023
End Date
February 28 2025
Last Update
January 9 2024
Active Locations (8)
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1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100070
2
Fujian provincial hospital
Fuzhou, Fujian, China, 350001
3
The First People's Hospital of Foshan
Foshan, Guangdong, China, 528000
4
The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China, 515041