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Active Clinical Trials

14-505

Active NCT:
02329327
Allegheny General Hospital
Allegheny General Hospital

Sponsor: 
Portola Pharmaceuticals
Contact: 

For more information, please contact Kelly Szabo at 412-359-8763 or Kelly.Szabo@ahn.org

14-505: Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor Who Have Acute Major Bleeding

Purpose: 

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.

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:

  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 with a hemoglobin level that, in the opinion of the investigator, will fall to ≤ 8 g/dL with resuscitation, OR
    • Acute symptomatic bleeding in a critical area or organ
  2. If bleeding is intracranial, the patient must have undergone a head CT or MRI scan demonstrating the intracranial bleeding
  3. Patient received or believed to have received one of the following within 18 hours prior to andexanet administration: apixaban, rivaroxaban, edoxaban or enoxparin

 

​Exclusion Criteria

  1. The patient is expected to undergo surgery in less than 12 hours, with the exception of minimally invasive 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. Expected survival of less than 1 month
  4. Recent history (within 2 weeks) of a diagnosed thrombotic event
  5. Severe sepsis or septic shock at the time of Screening
  6. Pregnant or a lactating female
  7. 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
  8. Treated with an investigational drug < 30 days prior to Screening