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| Name | Class |
|---|---|
| Dartmouth-Hitchcock Medical Center | OTHER |
| MaineHealth | OTHER |
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This is an open label study of apixaban for venous thromboembolism prevention in patients with newly diagnosed grade 4 glioma.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm study | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban | Drug | Open label |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy in prevention of venous thromboembolism | Incidence of VTE | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alissa A Thomas, MD | Contact | 802-847-8400 | alissa.thomas@med.uvm.edu | |
| Donna Silver | Contact | 802-656-5040 | irb@uvm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alissa A Thomas, MD | University of Vermont Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vermont Medical Center | Recruiting | Burlington | Vermont | 05401 | United States |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D001254 | Astrocytoma |
| D054556 | Venous Thromboembolism |
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C522181 | apixaban |
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Open label study of apixaban for VTE prevention in patients with newly diagnosed grade 4 glioma
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| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |