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

NCT03613402 | Withdrawn

• 1 other identifier: 18-025
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Venous Thromboses

Outcome Measures

Primary Outcomes (1)

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

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

  45 days

Secondary Outcomes (1)

• Bleeding rates at 45 days

  45 days

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

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

Sponsors & Collaborators

• Portola Pharmaceuticals: lead

Study Sites (1)

Durham

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: August 3, 2018
• Study Start: September 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

US (1)