Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor XA Inhibitor Who Have Acute Major Bleeding (Annexa-4), Amendment 6 - Annexa-4

Portola Pharmaceuticals, Inc.0 个研究点目标入组 479 人开始时间: 2017年8月2日最近更新: 2024年8月19日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Portola Pharmaceuticals, Inc.
入组人数: 479

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: N/a: Single Arm Study
盲法: Open (masking not used)

入排标准

年龄范围: 18 Years 至 one（—）
性别: All

入选标准

•1. Either the patient or his or her medical proxy (or legally acceptable designee) has been
•adequately informed of the nature and risks of the study and has given written informed
•consent prior to Screening.
•2. The patient must be at least 18 years old at the time of Screening.
•3. The patient must have an acute overt major bleeding episode requiring urgent reversal of
•anticoagulation. Acute major bleeding requiring urgent reversal of anticoagulation is
•defined by at least ONE of the following:
•Acute overt bleeding that is potentially life-threatening, e.g., with signs or symptoms of
•hemodynamic compromise, such as severe hypotension, poor skin perfusion, mental
•confusion, low urine output that cannot be otherwise explained.
•Acute overt bleeding associated with a fall in hemoglobin level by = 2 g/dL, OR
•a Hgb = 8 g/dL if no baseline Hgb is available.
•Acute bleeding in a critical area or organ, such as intraspinal, pericardial, or intracranial
•4. The patient, for whom the bleeding is intracranial or intraspinal must have undergone a CT
•or MRI scan demonstrating the bleeding.
•5. The patient received or is believed to have received one of the following within 18 hours
•prior to andexanet administration: apixaban, rivaroxaban, edoxaban, or enoxaparin (dose of
•enoxaparin = 1 mg/kg/d).
•6. For patients with ICH, there must be a reasonable expectation that andexanet treatment will commence within 2 hours of the baseline imaging evaluation.

排除标准

•1) Patients are excluded if they are scheduled to undergo surgery in less than 12 hours, with the
•exception of minimally invasive surgery/procedures (e.g., endoscopy, bronchoscopy, central
•lines, Burr holes - see more examples in Appendix G).
•2) A patient with ICH has any of the following:
•Glasgow Coma Score < 7
•Estimated intracerebral hematoma volume > 60 cc as assessed by the CT or MRI
•3) Patients with visible, musculoskeletal, or intra-articular bleeding as their qualifying bleed.
•4) The patient has an expected survival of less than 1 month.
•5) The patient has a recent history (within 2 weeks) of a diagnosed thrombotic event (TE)
•as follows: venous thromboembolism (VTE; e.g., deep vein thrombosis, pulmonary
•embolism, intracranial venous thrombosis), myocardial infarction, disseminated
•intravascular coagulation (DIC), cerebral vascular accident, transient ischemic attack,
•unstable angina pectoris hospitalization, or severe peripheral vascular disease within
•2 weeks prior to screening (see Appendix E for DIC scoring algorithm).
•6) The patient has severe sepsis or septic shock at the time of Screening (see definition
•Appendix F).
•7) The patient is pregnant or a lactating female.
•8) The patient has received any of the following drugs or blood products within 7 days or
•Vitamin K antagonist (VKA) (e.g., warfarin).
•Dabigatran.
•Prothrombin Complex Concentrate products (PCC, e.g., Kcentra®) or recombinant
•factor VIIa (rfVIIa) (e.g., NovoSeven®).
•Whole blood, plasma fractions. Note: Administration of platelets or packed red blood
•cells (PRBCs) is not an exclusion criterion.
•9) The patient was treated with an investigational drug < 30 days prior to Screening.
•10) Planned administration of PCC, fresh frozen plasma (FFP), or rfVIIa from Screening until
•within 12 hours after the end of the andexanet infusion.

研究者

发起方

Portola Pharmaceuticals, Inc.

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