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

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.

Study Overview

• Status: Terminated
• Conditions: Glioma, Malignant
• Intervention / Treatment: Other: Observation of ICH and VTE

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • UC Davis Comprehensive Cancer Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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).

Description

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
• Any other medical, social, logistical, or psychological reason, which in the opinion of the investigator, would preclude compliance with, or successful completion of, the study protocol
• Known active and clinically significant liver disease (e.g., hepatorenal syndrome)
• Known bacterial endocarditis
• Know uncontrolled hypertension: systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg; (subjects who have a transient, higher blood pressure elevation associated with acute PE [upper limit: systolic blood pressure 200 mm Hg or diastolic blood pressure 100 mm Hg] may enter the study;) elevated blood pressure that is persistent 1 - 2 days after the index DVT or PE should be treated according to local guidelines

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: Observation of ICH and VTE; The treating physician will initiate and prescribe the apixaban, the protocol will only observe and record intracranial pressure (ICP) and VTE incidences.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Deep venous thromboembolism (VTE) event incidence rate	Observe subject to determine the incidence of VTE during SOC observations.	1 year

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Investigators: Study Chair: Stuart A Grossman, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): August 5, 2022
• Study Completion (Actual): August 5, 2022

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): December 2, 2022
• Last Update Submitted That Met QC Criteria: December 1, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Glioma; ICH; Apixaban; LMWH; DVT
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Embolism and Thrombosis; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Hemorrhage; Glioma; Thromboembolism; Venous Thromboembolism; Intracranial Hemorrhages
• Other Study ID Numbers: ABTCv2-2102; IRB00242129 (Other Identifier: Johns Hopkins); J2026 (Other Identifier: Johns Hopkins)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No