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)

University of Vermont Medical Center

Burlington, Vermont, United States

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NCT05683808


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