Venous ThrombosesNCT03613402
BRAVO - Betrixaban Registry Using Real Time Observations in Acute Medical Illness to Assess Venous Thrombosis and Bleeding Outcomes
An observational study of Venous Thromboses, run by Portola Pharmaceuticals at 1 site in United States.
Trial summary
Part 1 - Evaluate the real-world implementation of extended prophylaxis with betrixaban in the acutely ill hospitalized medical population Part 2 - Describe patterns of Venous thromboembolism (VTE) prophylaxis in acutely ill medical patients who qualify for extended VTE prophylaxis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboses
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2018to Jan 2020
- 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: Acutely ill medical patients, hospitalized, prescribed therapy for VTE prophylaxis and who would qualify for extended prophylaxis (whether or not they receive prophylaxis).
Who may be able to join
- -Part 1 -
- Hospitalized acutely ill medical patient
- Patient prescribed betrixaban
- Signed informed consent
- Part 2 -
- Hospitalized acutely ill medical patient
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- Patient prescribed betrixaban OR must satisfy criteria a and b:
- Moderately or severely restricted immobility: patient restricted to bed for at least 24 hours (severe) or restricted to bed for at least 12 hours (moderate) during their hospitalization
- At least One additional risk factor:
- Age > 70 years D-dimer > 2x institutional Upper Limit of Normal (ULN) Obesity: Body mass index (BMI) > 30 kg/m2) History of pulmonary embolism (PE) or deep venous thrombosis (DVT) Active cancer (diagnosed, treated, or progressing in the past 6 months) History of thrombophilia Recent trauma or surgery (within 30 days prior to admission) Ongoing hormonal treatment ICU stay 3. Signed informed consent
Who cannot join
- Part 1 - 1. High bleeding risk - any of the following:
- Patient on dialysis
- Low platelet count (<50 per 109/L)
- Known bleeding disorder (congenital or acquired)
- Liver disease prohibitive to anticoagulation
- Bleeding within last 30 days
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- Use of Dual Anti-Platelet Therapy (DAPT)
- Part 2
- Patients who are on another oral anticoagulant (OAC) for any reason at the time of hospitalization and will remain on it
- Condition requiring use of OAC at admission, other than VTE prophylaxis (eg, acute VTE at admission)
- High bleeding risk any of the following:
- Patient on dialysis
- Low platelet count (<50 per 109/L)
- Known bleeding disorder (congenital or acquired)
- Liver disease prohibitive to anticoagulation
- Bleeding within last 30 days
- Use of Dual Anti-Platelet Therapy (DAPT)
Trial locations and contacts
1 site in 1 country.
About this study
Part 1 - Evaluate the real-world implementation of extended prophylaxis with betrixaban in the acutely ill hospitalized medical population Part 2 - Describe patterns of Venous thromboembolism (VTE) prophylaxis in acutely ill medical patients who qualify for extended VTE prophylaxis
- Conditions
- Venous Thromboses
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Patients at risk of VTE who are prescribed betrixaban to prevent VTE | |
| Cohort 2 | Patients at risk of VTE who are prescribed betrixaban or other VTE prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombotic Events at 45 days: VTE, MI, Stroke, Transient ischemic attack (TIA)
Thrombotic Events at 45 days: VTE, MI, Stroke, TIA
Measured: 45 days
Secondary outcomes (1)
Bleeding rates at 45 days
Bleeding rates at 45 days
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study startSep 2018 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Why it stopped: Due to slow enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThrombosesStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portola Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613402
- Sponsor's protocol ID
- 18-025
- Status last verified
- Feb 2023
- First submitted
- 19 Jul 2018
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRAVO - Betrixaban Registry Using Real Time Observations in Acute Medical Illness to Assess Venous Thrombosis and Bleeding Outcomes
- ClinicalTrials.gov ID
- NCT03613402
- Acronym / sponsor ID
- 18-025
- Conditions
- Venous Thromboses
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Due to slow enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Portola PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2018 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 3 Aug 2018 (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.
Part 1 - Evaluate the real-world implementation of extended prophylaxis with betrixaban in the acutely ill hospitalized medical population Part 2 - Describe patterns of Venous thromboembolism (VTE) prophylaxis in acutely ill medical patients who qualify for extended VTE prophylaxis
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Patients at risk of VTE who are prescribed betrixaban to prevent VTE |
| Cohort 2 | – | –Patients at risk of VTE who are prescribed betrixaban or other VTE prophylaxis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acutely ill medical patients, hospitalized, prescribed therapy for VTE prophylaxis and who would qualify for extended prophylaxis (whether or not they receive prophylaxis).
Key inclusion criteria (10 listed)
- -Part 1 -
- Hospitalized acutely ill medical patient
- Patient prescribed betrixaban
- Signed informed consent
- Part 2 -
Key exclusion criteria (17 listed)
- Part 1 - 1. High bleeding risk - any of the following:
- Part 2
- Patients who are on another oral anticoagulant (OAC) for any reason at the time of hospitalization and will remain on it
- Condition requiring use of OAC at admission, other than VTE prophylaxis (eg, acute VTE at admission)
- High bleeding risk any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Thrombotic Events at 45 days: VTE, MI, Stroke, Transient ischemic attack (TIA)
Time frame: 45 days
Thrombotic Events at 45 days: VTE, MI, Stroke, TIA
1 secondary outcome
Bleeding rates at 45 days
Time frame: 45 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboses, run by Portola Pharmaceuticals at 1 site 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 10 inclusion and 17 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: withdrawn, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 withdrawn before enrolling participants, so there are no results.
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?
Thrombotic Events at 45 days: VTE, MI, Stroke, Transient ischemic attack (TIA) (time frame: 45 days). 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 21 Feb 2023.