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RecruitingInterventionalPhase 2

Venous Thromboembolism Prevention in Outpatients With Glioma

NCT ID: NCT05683808Sponsor: University of Vermont Medical CenterLast updated: 2026-01-30

Summary

This is an open label study of apixaban for venous thromboembolism prevention in patients with newly diagnosed grade 4 glioma.

Detailed description

Patients with primary brain tumors, including glioblastoma and astrocytoma, are at high risk of developing venous thromboemboli (VTE) as a comorbid condition. Prior studies have demonstrated safety and efficacy of primary pharmacological prevention of VTE using blood thinning medications, including apixaban. These studies have included a small cohort of patients with grade 4 glioma. The purpose of this study is to gather additional safety data regarding the use of apixaban for primary prevention of VTE in patients with newly diagnosed grade 4 glioma.

Arms & interventions

  • DrugApixaban

    Open label

Outcome measures

Primary

  • Safety of apixaban as determined by bleeding risk

    CTCAE 5 reporting of grade 2 non-Central Nervous System (CNS) hemorrhage or grade 2 new CNS hemorrhage.

    Time frame: 6 months

Secondary

  • Efficacy in prevention of venous thromboembolism

    Time frame: 6 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * Histologic diagnosis of malignant glioma, World Health Organization (WHO) grade 4, including glioblastoma and astrocytoma, based on recent biopsy or resection. * Age 18 and old * Karnofsky performance status (KPS) 60-100 * Acceptable labs, including platelets of greater than or equal to 100,000, glomerular filtration rate (GFR) greater than or equal to 25. * Ability to provide informed consent. * Planning for treatment with radiation and chemotherapy. Exclusion Criteria: * Evidence of deep venous thrombosis (DVT), pulmonary embolism (PE), or cerebral vein thrombosis (CVT) within 6 months prior to enrollment on the study. * Pregnancy. * Significant bleeding risk including: history of symptomatic intracranial hemorrhage, active bleeding at time of study registration, clinically significant bleeding within 14 days of study registration, intracranial trauma in the past 6 months, including stroke or traumatic brain injury, major surgery or major procedure within 48 hours. * Allergy to apixaban or contraindication to prophylactic anticoagulation. Contraindications include patients who are currently on unfractionated heparin, low molecular weight heparin, heparin derivatives (examples: fondaparinux), or other direct oral anticoagulants (examples: dabigatran, edoxaban, rivaroxaban), who are either unable or unable to discontinue these agents in favor of the investigational drug. Apixaban is also contraindicated in patients who are on strong CYP3A4 inhibitor and P-glycoprotein inhibitors. * Indication for full anticoagulation (i.e. atrial fibrillation, mechanical valve, etc.). * Estimated life expectancy of \<3 months.

Study locations (1)

University of Vermont Medical Center

Burlington, Vermont, 05401

Recruiting
Venous Thromboembolism Prevention in Outpatients With Glioma | Cancerify