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

Withdrawn before enrolling

Conditions studied: Venous Thromboses

In brief

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

Key facts

Study ID

NCT03613402

Run by

Portola Pharmaceuticals

People needed

0

Starts

2018-09-01

Expected to finish

2020-01-01

Last updated by the study team

2023-02-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Part 1 -
• Hospitalized acutely ill medical patient
• Patient prescribed betrixaban
• Signed informed consent
• Part 2 -
• Hospitalized acutely ill medical patient
• 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

You may not qualify if…

• 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
• 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)

Where it is running

• Durham — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.