drugset / Trial / NCT06196918
Efficacy and Safety of Rivaroxaban in the Prevention of Venous Thromboembolism in Glioma Patients
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2023-11-01
- Primary completion
- 2024-08-31
- Completion
- 2025-02-28
Publications
- Background Heit JA, Silverstein MD, Mohr DN, Petterson TM, O'Fallon WM, Melton LJ 3rd. Risk factors for deep vein thrombosis and pulmonary embolism: a population-based case-control study. Arch Intern Med. 2000 Mar 27;160(6):809-15. doi: 10.1001/archinte.160.6.809.
- Background Khorana AA, Francis CW, Culakova E, Kuderer NM, Lyman GH. Thromboembolism is a leading cause of death in cancer patients receiving outpatient chemotherapy. J Thromb Haemost. 2007 Mar;5(3):632-4. doi: 10.1111/j.1538-7836.2007.02374.x. No abstract available.
- Background Horsted F, West J, Grainge MJ. Risk of venous thromboembolism in patients with cancer: a systematic review and meta-analysis. PLoS Med. 2012;9(7):e1001275. doi: 10.1371/journal.pmed.1001275. Epub 2012 Jul 31.
- Background Gerber DE, Grossman SA, Streiff MB. Management of venous thromboembolism in patients with primary and metastatic brain tumors. J Clin Oncol. 2006 Mar 10;24(8):1310-8. doi: 10.1200/JCO.2005.04.6656.
- Background Knovich MA, Lesser GJ. The management of thromboembolic disease in patients with central nervous system malignancies. Curr Treat Options Oncol. 2004 Dec;5(6):511-7. doi: 10.1007/s11864-004-0039-x.
- Background Tabori U, Beni-Adani L, Dvir R, Burstein Y, Feldman Z, Pessach I, Rechavi G, Constantini S, Toren A. Risk of venous thromboembolism in pediatric patients with brain tumors. Pediatr Blood Cancer. 2004 Nov;43(6):633-6. doi: 10.1002/pbc.20149.
- Background Brandes AA, Scelzi E, Salmistraro G, Ermani M, Carollo C, Berti F, Zampieri P, Baiocchi C, Fiorentino MV. Incidence of risk of thromboembolism during treatment high-grade gliomas: a prospective study. Eur J Cancer. 1997 Sep;33(10):1592-6. doi: 10.1016/s0959-8049(97)00167-6.
- Background Simanek R, Vormittag R, Hassler M, Roessler K, Schwarz M, Zielinski C, Pabinger I, Marosi C. Venous thromboembolism and survival in patients with high-grade glioma. Neuro Oncol. 2007 Apr;9(2):89-95. doi: 10.1215/15228517-2006-035. Epub 2007 Feb 27.
- Background Dhami MS, Bona RD, Calogero JA, Hellman RM. Venous thromboembolism and high grade gliomas. Thromb Haemost. 1993 Sep 1;70(3):393-6.
- Background Collins A, Sundararajan V, Brand CA, Moore G, Lethborg C, Gold M, Murphy MA, Bohensky MA, Philip J. Clinical presentation and patterns of care for short-term survivors of malignant glioma. J Neurooncol. 2014 Sep;119(2):333-41. doi: 10.1007/s11060-014-1483-5. Epub 2014 Jun 3.
- Background Tucha O, Smely C, Preier M, Lange KW. Cognitive deficits before treatment among patients with brain tumors. Neurosurgery. 2000 Aug;47(2):324-33; discussion 333-4. doi: 10.1097/00006123-200008000-00011.
- Background Chaichana KL, Pendleton C, Jackson C, Martinez-Gutierrez JC, Diaz-Stransky A, Aguayo J, Olivi A, Weingart J, Gallia G, Lim M, Brem H, Quinones-Hinojosa A. Deep venous thrombosis and pulmonary embolisms in adult patients undergoing craniotomy for brain tumors. Neurol Res. 2013 Mar;35(2):206-11. doi: 10.1179/1743132812Y.0000000126. Epub 2012 Dec 13.
- Background Jenkins EO, Schiff D, Mackman N, Key NS. Venous thromboembolism in malignant gliomas. J Thromb Haemost. 2010 Feb;8(2):221-7. doi: 10.1111/j.1538-7836.2009.03690.x. Epub 2009 Nov 13.
- Background Misch M, Czabanka M, Dengler J, Stoffels M, Auf G, Vajkoczy P, Stockhammer F. D-dimer elevation and paresis predict thromboembolic events during bevacizumab therapy for recurrent malignant glioma. Anticancer Res. 2013 May;33(5):2093-8.
- Background Perry JR, Julian JA, Laperriere NJ, Geerts W, Agnelli G, Rogers LR, Malkin MG, Sawaya R, Baker R, Falanga A, Parpia S, Finch T, Levine MN. PRODIGE: a randomized placebo-controlled trial of dalteparin low-molecular-weight heparin thromboprophylaxis in patients with newly diagnosed malignant glioma. J Thromb Haemost. 2010 Sep;8(9):1959-65. doi: 10.1111/j.1538-7836.2010.03973.x.
- Background Mohamed MFH, ElShafei MN, Ahmed MB, Abdalla LO, Ahmed I, Elzouki AN, Danjuma MI. The Net Clinical Benefit of Rivaroxaban Compared to Low-Molecular-Weight Heparin in the Treatment of Cancer-Associated Thrombosis: Systematic Review and Meta-Analysis. Clin Appl Thromb Hemost. 2021 Jan-Dec;27:1076029620940046. doi: 10.1177/1076029620940046.
- Background Young AM, Marshall A, Thirlwall J, Chapman O, Lokare A, Hill C, Hale D, Dunn JA, Lyman GH, Hutchinson C, MacCallum P, Kakkar A, Hobbs FDR, Petrou S, Dale J, Poole CJ, Maraveyas A, Levine M. Comparison of an Oral Factor Xa Inhibitor With Low Molecular Weight Heparin in Patients With Cancer With Venous Thromboembolism: Results of a Randomized Trial (SELECT-D). J Clin Oncol. 2018 Jul 10;36(20):2017-2023. doi: 10.1200/JCO.2018.78.8034. Epub 2018 May 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rivaroxaban | Other / unclassified | 10 mg | Oral |