Using Rivaroxaban to prevent blood clots in glioma patients
Efficacy and Safety of Rivaroxaban in the Prevention of Venous Thromboembolism in Glioma Patients With Postoperative Lower Extremity Dyskinesia
This study is testing if the blood thinner Rivaroxaban can help prevent blood clots in patients with malignant gliomas after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 8 sites (Beijing, Beijing and 7 other locations) |
| Trial ID | NCT06196918 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of Rivaroxaban, an oral anticoagulant, in preventing venous thromboembolism (VTE) in patients with malignant gliomas who experience postoperative lower extremity dyskinesia. Given the high risk of VTE in glioma patients, particularly after surgery, this trial aims to establish whether Rivaroxaban can effectively reduce the incidence of blood clots compared to a placebo. Participants will be closely monitored for any adverse effects and the overall effectiveness of the treatment in preventing VTE. The study includes patients aged 18-80 years who are newly diagnosed with glioma and agree to surgical resection.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with newly diagnosed, untreated glioma and postoperative lower extremity dyskinesia.
Not a fit: Patients with severe organ dysfunction, acute gastrointestinal symptoms, or a history of anticoagulant use may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of venous thromboembolism in glioma patients, improving their postoperative outcomes.
How similar studies have performed: While the use of Rivaroxaban in other cancer-related contexts has shown promise, this specific application in glioma patients is novel and requires further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Beijing, Beijing and 7 other locations
- Beijing Tiantan Hospital — Beijing, Beijing, China (Recruiting)
- Fujian provincial hospital — Fuzhou, Fujian, China (Recruiting)
- The First People's Hospital of Foshan — Foshan, Guangdong, China (Recruiting)
- The First Affiliated Hospital of Shantou University Medical College — Shantou, Guangdong, China (Recruiting)
- Longgang Central Hospital of Shenzhen — Shenzhen, Guangdong, China (Recruiting)
- Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (Recruiting)
- Hainan general hospital — Haikou, Hainan, China (Recruiting)
- The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Guanglong Huang, M.D. — Nanfang Hospital, Southern Medical University
- Study coordinator: Tianshi Que, M.D.
- Email: qtssjwk@126.com
- Phone: +86-020-61641806
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.