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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Page 1 of 2 (8 locations)

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