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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00242129 | Other Identifier | Johns Hopkins | |
| J2026 | Other Identifier | Johns Hopkins |
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lack of funds. Only 1 patient was enrolled
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Glioma patients with history of venous thromboembolism (VTE) treated on low molecular weight heparin (LMWH) and who decided with their physician to convert to Apixaban (oral drug) will be enrolled into our study and will collect data regarding recurrent VTE and Intracranial hemorrhage and the incidence of these events.
Primary Objectives To estimate the incidence of intracranial hemorrhage (ICH) in glioma patients with history of venous thromboembolism (VTE) after the conversion from low molecular weight heparin (LMWH) injections to oral Apixaban.
Secondary Objective To estimate the incidence of recurrent VTE in glioma patients with history of venous thromboembolism after the conversion from low molecular weight heparin (LMWH) injections to oral Apixaban.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort Apixaban | patients who have switched from low molecular weight heparin (LMWH) to apixaban at the recommended dose of the treating physician. FDA approved dose 10 mg twice daily (BID) for 7 days followed by 5 mg PO BID OR physician prescribed dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation of ICH and VTE | Other | The treating physician will initiate and prescribe the apixaban, the protocol will only observe and record intracranial pressure (ICP) and VTE incidences. |
| Measure | Description | Time Frame |
|---|---|---|
| Intracranial Hemorrhage (ICH) event incidence rate | Observe subject to determine the incidence of ICH during standard of care (SOC) observations. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Deep venous thromboembolism (VTE) event incidence rate | Observe subject to determine the incidence of VTE during SOC observations. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients greater than or equal to 18 years of age who have had a pathologically confirmed supra-tentorial primary brain tumor and a history of deep venous thrombosis (DVT) and/or pulmonary embolism (PE).
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| Name | Affiliation | Role |
|---|---|---|
| Stuart A Grossman, MD | Johns Hopkins University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Comprehensive Cancer Center | Sacramento | California | 95817 | United States | ||
| Johns Hopkins |
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| ID | Term |
|---|---|
| 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 |
|---|---|
| C052671 | vinyltriethoxysilane |
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| Baltimore |
| Maryland |
| 21287 |
| United States |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |