Clinical trial NCT03613402: BRAVO - Betrixaban Registry Using Real Time Observations in Acute Medical Illness to Assess Venous Thrombosis and Bleeding Outcomes
Official title: BRAVO - Betrixaban Registry Using Real Time Observations in Acute Medical Illness to Assess Venous Thrombosis and Bleeding Outcomes
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Venous Thromboses
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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


Eligibility criteria: 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)

Primary outcomes:
measure: Thrombotic Events at 45 days: VTE, MI, Stroke, Transient ischemic attack (TIA)
timeFrame: 45 days
Secondary outcomes:
measure: Bleeding rates at 45 days
timeFrame: 45 days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham
state: North Carolina
Study officials:
References: