Efficacy and Safety of Rivaroxaban in the Prevention of Venous Thromboembolism in Glioma Patients With Postoperative Lower Extremity Dyskinesia

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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 considered as a high-risk factor for venous thromboembolism. Rivaroxaban, as an oral anticoagulants, has similar effect in the prevention and treatment of tumor-related venous thromboembolism compared to low molecular weight heparin. Given the lack of prospective supporting data, the efficacy and safety of rivaroxaban in the prevention of postoperative venous thromboembolism in glioma patients with postoperative lower extremity dyskinesia need to be established.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Tiantan Hospital
RECRUITING
Beijing
The First People's Hospital of Foshan
RECRUITING
Foshan
Fujian provincial hospital
RECRUITING
Fuzhou
Hainan general hospital
RECRUITING
Haikou
The First Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Guangxi Medical University Cancer Hospital
RECRUITING
Nanning
The First Affiliated Hospital of Shantou University Medical College
RECRUITING
Shantou
Longgang Central Hospital of Shenzhen
RECRUITING
Shenzhen
Contact Information
Primary
Tianshi Que, M.D.
qtssjwk@126.com
+86-020-61641806
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2025-02-28
Participants
Target number of participants: 320
Treatments
Experimental: Rivaroxaban group
Patients with highly suspected, newly diagnosed, untreated glioma undergo surgical resection. CT scan within 24 hours after surgery is performed to rule out intracranial hemorrhage and/or infarction. Then those patients with postoperative lower extremity dyskinesia are treated with rivaroxaban (10 mg/day) and compression stockings until 1 month after surgery.
Active_comparator: Placebo group
Patients with highly suspected, newly diagnosed, untreated glioma undergo surgical resection. CT scan within 24 hours after surgery is performed to rule out intracranial hemorrhage and/or infarction. Then those patients with postoperative lower extremity dyskinesia are treated with placebo and compression stockings until 1 month after surgery.
Sponsors
Leads: Nanfang Hospital, Southern Medical University

This content was sourced from clinicaltrials.gov