Glioma, MalignantNCT04895553
Incidence of Intracranial Hemorrhage in Glioma Patients With Venous Thromboembolism Converted From LMWH to Apixaban
An observational study of Glioma, Malignant, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Malignant
- What is being tested?
- Observation of ICH and VTE
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2021to 5 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins
Baltimore, Maryland, 21287
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817
About this study
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.
Read the 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.
- Conditions
- Glioma, Malignant
- Being tested
- Observation of ICH and VTE
- Keywords
- Apixaban, Glioma, ICH, DVT, LMWH
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of ICH and VTEOther
The treating physician will initiate and prescribe the apixaban, the protocol will only observe and record intracranial pressure (ICP) and VTE incidences.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Observation of ICH and VTE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial Hemorrhage (ICH) event incidence rate
Observe subject to determine the incidence of ICH during standard of care (SOC) observations.
Measured: 1 year
Secondary outcomes (1)
Deep venous thromboembolism (VTE) event incidence rate
Observe subject to determine the incidence of VTE during SOC observations.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start1 Aug 2021
- Primary completion5 Aug 2022
- Study completion5 Aug 2022
Why it stopped: lack of funds. Only 1 patient was enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioma, MalignantStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stuart A Grossman, MD, Study chair, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895553
- Sponsor's protocol ID
- ABTCv2-2102
- Other IDs
- IRB00242129, J2026
- Status last verified
- Dec 2022
- First submitted
- 17 May 2021
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Intracranial Hemorrhage in Glioma Patients With Venous Thromboembolism Converted From LMWH to Apixaban
- ClinicalTrials.gov ID
- NCT04895553
- Acronym / sponsor ID
- ABTCv2-2102
- Conditions
- Glioma, Malignant
- Keywords
- Apixaban, Glioma, ICH, DVT, LMWH
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: lack of funds. Only 1 patient was enrolled
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 5 Aug 2022 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort Apixaban | – | Other: Observation of ICH and VTEpatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation of ICH and VTEThe treating physician will initiate and prescribe the apixaban, the protocol will only observe and record intracranial pressure (ICP) and VTE incidences. | Other | Cohort Apixaban |
Primary outcome
Intracranial Hemorrhage (ICH) event incidence rate
Time frame: 1 year
Observe subject to determine the incidence of ICH during standard of care (SOC) observations.
1 secondary outcome
Deep venous thromboembolism (VTE) event incidence rate
Time frame: 1 year
Results and safety
The study was stopped early (reason given: lack of funds. Only 1 patient was enrolled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart A Grossman, MD study chair
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma, Malignant, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of funds. Only 1 patient was enrolled). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial Hemorrhage (ICH) event incidence rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2022.