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

Venous Thromboses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03613402
• Other study ID #: 18-025
• Status: Withdrawn
• Start date: September 2018
• Est. completion date: January 2020

Study information

• Verified date: February 2023
• Source: Alexion Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Thrombosis
• Venous Thromboses
• Venous Thrombosis

Locations

Country	Name	City	State
United States	Durham	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Portola Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thrombotic Events at 45 days: VTE, MI, Stroke, Transient ischemic attack (TIA)	Thrombotic Events at 45 days: VTE, MI, Stroke, TIA	45 days
Secondary	Bleeding rates at 45 days	Bleeding rates at 45 days	45 days