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

Glioma, Malignant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04895553
• Other study ID #: ABTCv2-2102
• Secondary ID: IRB00242129J2026
• Status: Terminated
• Start date: August 1, 2021
• Est. completion date: August 5, 2022

Study information

• Verified date: December 2022
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: August 5, 2022
• Est. primary completion date: August 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioma
• Glioma, Malignant
• Hemorrhage
• Intracranial Hemorrhages
• Thromboembolism
• Venous Thromboembolism

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins	Baltimore	Maryland
United States	UC Davis Comprehensive Cancer Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intracranial Hemorrhage (ICH) event incidence rate	Observe subject to determine the incidence of ICH during standard of care (SOC) observations.	1 year
Secondary	Deep venous thromboembolism (VTE) event incidence rate	Observe subject to determine the incidence of VTE during SOC observations.	1 year