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

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

Study Overview

• Status: Withdrawn
• Conditions: Venous Thromboses

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Durham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thrombotic Events at 45 days: VTE, MI, Stroke, Transient ischemic attack (TIA)	Thrombotic Events at 45 days: VTE, MI, Stroke, TIA	45 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding rates at 45 days	Bleeding rates at 45 days	45 days

Collaborators and Investigators

• Sponsor: Portola Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2018
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: July 19, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: 18-025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No