RecruitingPhase 2NCT05683808
Venous Thromboembolism Prevention in Outpatients With Glioma
Sponsor
University of Vermont Medical Center
Enrollment
40 participants
Start Date
Jan 16, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
This is an open label study of apixaban for venous thromboembolism prevention in patients with newly diagnosed grade 4 glioma.
Eligibility
Min Age: 18 Years
Inclusion Criteria6
- 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 Criteria6
- 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.
Interventions
DRUGApixaban
Open label
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05683808
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