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

NCT04895553 | Terminated DMC

• 3 other identifiers: ABTCv2-2102IRB00242129J2026
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Glioma, Malignant

Keywords

Apixaban; Glioma; ICH; DVT; LMWH

Outcome Measures

Primary Outcomes (1)

• Intracranial Hemorrhage (ICH) event incidence rate

  Observe subject to determine the incidence of ICH during standard of care (SOC) observations.

  1 year

Secondary Outcomes (1)

• Deep venous thromboembolism (VTE) event incidence rate

  1 year

Study Arms (1)

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

Interventions

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.

Cohort Apixaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (2)

UC Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Glioma

Interventions

vinyltriethoxysilane

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Stuart A Grossman, MD

  Johns Hopkins University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 20, 2021
• Study Start: August 1, 2021
• Primary Completion: August 5, 2022
• Study Completion: August 5, 2022
• Last Updated: December 2, 2022

Record last verified: 2022-12

Locations

US (2)