Loading clinical trials...

Incidence of Intracranial Hemorrhage in Glioma Patients With Venous Thromboembolism Converted From LMWH to Apixaban | Clinical Trials | Clareo Health

TERMINATED

Incidence of Intracranial Hemorrhage in Glioma Patients With Venous Thromboembolism Converted From LMWH to Apixaban

NCT04895553•Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must be 18 years of age or older;
•Patients must have had a pathologically confirmed supra-tentorial primary brain tumor
•Patients must have history of deep venous thrombosis (DVT) and/or pulmonary embolism (PE)
•Patients must have been treated with low molecule weight heparin for ≥ 5 days
•Patients must be able to provide written informed consent
•Patients must have non contrast CT that is negative for intra-cranial bleed at least 5 days post initiation of LMWH and prior to initiation (within 7 days) of Apixaban
•Must be decision by patient and his physician to convert to Apixaban

Exclusion Criteria

•Patients with a plan less than 6 months of anticoagulation for most recent DVT or PE
•Patients with allergic reaction to Apixaban
•Patients with active bleeding or high risk for bleeding contraindicating treatment with LMWH
•Patients with planned surgery in the next 2 weeks
•Patients previously treated with Apixaban
•Patients requiring Acetylsalicylic Acid (ASA) greater than165 mg/day at enrollment
•Patients requiring dual anti-platelet therapy (ASA plus clopidogrel or ASA plus ticlopidine) at enrollment.
•Subjects with transition for dual anti-platelet therapy or monotherapy prior to enrollment will be eligible for the study
•Patients who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness
•Any condition, which in the opinion of the investigator, would put the subject at an unacceptable risk from participating in the study
+4 more criteria

Locations (2)

UC Davis Comprehensive Cancer Center

Sacramento, California, United States

Johns Hopkins

Baltimore, Maryland, United States

Key Dates

Start Date

August 1, 2021

Primary Completion Date

August 5, 2022

Completion Date

August 5, 2022

Last Updated

December 2, 2022

Enrollment

ACTUAL participants

Conditions

Glioma, Malignant

Interventions

Observation of ICH and VTE

OTHER

Window of Opportunity Study of DSP-0390 in Gliomas

NCT06636162

Glioma, MalignantGrade II Glioma+1 more

View study

RECRUITINGNA

Efficacy of a Mixed Distancial Neuropsychological Rehabilitation Program in Patients With Grade 2 or 3 Diffuse Glioma

NCT06468176

Glioma, Malignant

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 2, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Incidence of Intracranial Hemorrhage in Glioma Patients With Venous Thromboembolism Converted From LMWH to Apixaban

Inclusion Criteria

Exclusion Criteria

Window of Opportunity Study of DSP-0390 in Gliomas

Efficacy of a Mixed Distancial Neuropsychological Rehabilitation Program in Patients With Grade 2 or 3 Diffuse Glioma

FET PET in Differentiating Tumour Progression From Pseudoprogression in High Grade Glioma

Clinical Study on the Safety and Efficacy of TS-2021 in the Treatment of Recurrent Malignant Glioma

Niraparib In Recurrent IDH 1/2 Gliomas

An Integrated Radio-immunological Approach