Efficacy and Safety of Rivaroxaban in the Prevention of Venous Thromboembolism in Glioma Patients

NCT06196918 | Unknown

• 1 other identifier: NFEC-2023-314
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 8

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 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.

Conditions

Glioma, Malignant

Keywords

Glioma; Rivaroxaban; Venous Thromboembolism; Dyskinesia

Outcome Measures

Primary Outcomes (1)

• Venous thromboembolism

  The occurrence of venous thromboembolism, including pulmonary embolism and venous thrombosis of the lower extremities.

  6 months

Secondary Outcomes (2)

• Fatal hemorrhage

  6 months

• Non-fatal hemorrhage

  6 months

Study Arms (2)

Rivaroxaban group

EXPERIMENTAL

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.

Drug: Rivaroxaban 10 MG

Placebo group

ACTIVE COMPARATOR

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.

Drug: Placebo

Interventions

Rivaroxaban 10 MG DRUG

Patients with postoperative lower extremity dyskinesia are treated with rivaroxaban (10 mg/day) and compression stockings until 1 month after surgery.

Also known as: Jiangsu Zhongbang pharmaceutical CO., LTD; Serial numbers: H20203733

Rivaroxaban group

Placebo DRUG

Patients with postoperative lower extremity dyskinesia are treated with placebo (10 mg/day) and compression stockings until 1 month after surgery.

Also known as: Jiangsu Zhongbang pharmaceutical CO., LTD

Placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (8)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

RECRUITING

Fujian provincial hospital

Fuzhou, Fujian, 350001, China

RECRUITING

The First People's Hospital of Foshan

Foshan, Guangdong, 528000, China

RECRUITING

The First Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, 515041, China

RECRUITING

Longgang Central Hospital of Shenzhen

Shenzhen, Guangdong, 518116, China

RECRUITING

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, 530021, China

RECRUITING

Hainan general hospital

Haikou, Hainan, 570311, China

RECRUITING

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

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MeSH Terms

Conditions

Glioma; Venous Thromboembolism; Dyskinesias

Interventions

Rivaroxaban; Long-Term Synaptic Depression

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Guanglong Huang, M.D.

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tianshi Que, M.D.

CONTACT

+86-020-61641806; qtssjwk@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2023
• First Posted: January 9, 2024
• Study Start: November 1, 2023
• Primary Completion: August 31, 2024
• Study Completion: February 28, 2025
• Last Updated: January 9, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)