NCT03613402撤回不适用
BRAVO - Betrixaban Registry Using Real Time Observations in Acute Medical Illness to Assess Venous Thrombosis and Bleeding Outcomes
Portola Pharmaceuticals1 个研究点 分布在 1 个国家开始时间: 2018年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Thrombotic Events at 45 days: VTE, MI, Stroke, Transient ischemic attack (TIA)
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized acutely ill medical patient
- •Patient prescribed betrixaban
- •Signed informed consent
- •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
- •Signed informed consent
排除标准
- •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)
- •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)
结局指标
主要结局
Thrombotic Events at 45 days: VTE, MI, Stroke, Transient ischemic attack (TIA)
时间窗: 45 days
Thrombotic Events at 45 days: VTE, MI, Stroke, TIA
次要结局
- Bleeding rates at 45 days(45 days)
研究者
研究点 (1)
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