A Study in Patients With Acute Major Bleeding to Evaluate the Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Direct and Indirect Oral Anticoagulants (Extension Study)
A Study in Patients With Acute Major Bleeding to Evaluate the Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Direct and Indirect Oral Anticoagulants (Extension Study)
The purpose of this study is to evaluate the hemostatic efficacy of andexanet alfa in
 patients receiving a factor Xa inhibitor who are experiencing an acute major bleed. The
 safety of andexanet will also be studied.
Inclusion:

 1. Acute major bleeding episode requiring urgent reversal of anticoagulation; defined by
 at least one of the following:

 -  Acute bleeding that is potentially life-threatening, OR

 -  Acute bleeding associated with a fall in hemoglobin level by ≥2 g/dL, OR

 -  Acute bleeding associated with a hemoglobin level of ≤8 g/dL if no baseline
 hemoglobin is available, OR

 -  Acute bleeding in a critical area or organ such as intraspinal, pericardial, or
 intracranial.

 2. If bleeding is intracranial or intraspinal, the patient must have undergone a head CT
 or MRI scan demonstrating the bleeding.

 3. Patient received or is believed to have received one of the following within 18 hours
 prior to andexanet administration: apixaban, rivaroxaban, edoxaban or enoxaparin.

 4. For patients with intracranial bleeding, there must be a reasonable expectation that
 andexanet treatment will commence within 2 hours of the baseline imaging evaluation.

 Exclusion:

 1. The patient is scheduled to undergo surgery in less than 12 hours, with the exception
 of minimally invasive surgery/procedures.

 2. A patient with an intracerebral hemorrhage has any of the following:

 -  Glasgow coma score < 7, OR

 -  Intracerebral hematoma > 60 cc as assessed by CT or MRI

 3. Patients with visible, musculoskeletal or intra-articular bleeding as their qualifying
 bleed.

 4. Expected survival of less than 1 month

 5. Recent history (within 2 weeks) of a diagnosed thrombotic event (TE) as follows:
 venous thromboembolism, 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.

 6. Severe sepsis or septic shock at the time of Screening.

 7. Pregnant or a lactating female.

 8. Patient has received any of the following drugs or blood products within 7 days of
 Screening:

 -  Vitamin K antagonist (VKA)

 -  Dabigatran

 -  Prothrombin Complex Concentrate products (PCC) or recombinant factor VIIa
 (rfVIIa)

 -  Whole blood, plasma fractions

 9. 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.