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



Status:Suspended
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:12/5/2018
Start Date:October 2019
End Date:January 2020

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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


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:

- 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)
We found this trial at
1
site
Durham, North Carolina 27710
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from
Durham, NC
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