CClinicalTrials.gg
WithdrawnNCT03613402Updated Feb 21, 2023

BRAVO - Betrixaban Registry Using Real Time Observations in Acute Medical Illness to Assess Venous Thrombosis and Bleeding Outcomes

An observational study in Venous Thromboses, sponsored by Portola Pharmaceuticals. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-21.

Sponsored by Portola Pharmaceuticals · Observational

Why this study was withdrawn
Due to slow enrollment.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
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Study 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

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Conditions studied

  • Venous Thromboses
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In context

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.

Browse Thrombosis studies →

Lead sponsor

Portola Pharmaceuticals is the lead sponsor of 23 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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).

Inclusion criteria

-Part 1 -

  1. Hospitalized acutely ill medical patient
  2. Patient prescribed betrixaban
  3. Signed informed consent

Part 2 -

  1. Hospitalized acutely ill medical patient
  2. Patient prescribed betrixaban OR must satisfy criteria a and b:

    1. 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
    2. 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

Exclusion criteria

Exclusion Criteria:

  • Part 1 - 1. High bleeding risk - any of the following:

    1. Patient on dialysis
    2. Low platelet count (\<50 per 109/L)
    3. Known bleeding disorder (congenital or acquired)
    4. Liver disease prohibitive to anticoagulation
    5. Bleeding within last 30 days
    6. Use of Dual Anti-Platelet Therapy (DAPT)

Part 2

  1. Patients who are on another oral anticoagulant (OAC) for any reason at the time of hospitalization and will remain on it
  2. Condition requiring use of OAC at admission, other than VTE prophylaxis (eg, acute VTE at admission)
  3. High bleeding risk any of the following:

    1. Patient on dialysis
    2. Low platelet count (\<50 per 109/L)
    3. Known bleeding disorder (congenital or acquired)
    4. Liver disease prohibitive to anticoagulation
    5. Bleeding within last 30 days
    6. Use of Dual Anti-Platelet Therapy (DAPT)
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

  1. Thrombotic Events at 45 days: VTE, MI, Stroke, Transient ischemic attack (TIA)

    Thrombotic Events at 45 days: VTE, MI, Stroke, TIA

    Time frame: 45 days

Secondary outcomes

  1. Bleeding rates at 45 days

    Bleeding rates at 45 days

    Time frame: 45 days

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Study locations

1 site
  • Durham
    Durham, North Carolina 27705, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03613402
Lead sponsor
Portola Pharmaceuticals
Responsible party
Sponsor
First posted
Aug 3, 2018
Start date
Sep 2018 (estimated)
Primary completion
Jan 2020 (estimated)
Completion
Jan 2020 (estimated)
Last update
Feb 21, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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