Research & Innovation

Dova AVA-PST-320

Clinical Trials

SLUHN 2018-52

An Open-Label Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Subjects with Thrombocytopenia Scheduled for a Surgical Procedure

Physician & Study Coordinator

Physician

Stanislaw P Stawicki, M.D.

Stanislaw Stawicki, MD  

Study Coordinator

Susan Hahn
484-526-7825

susan.hahn2@sluhn.org

Close

Synopsis

Synopsis: You are being asked to participate in this research study because you have thrombocytopenia and are scheduled to undergo an operation to a site such as your eye, brain, etc. or an operation with a high risk of bleeding. Thrombocytopenia is when your blood has a lower than normal number of blood cells called platelets. Platelets travel through your blood vessels and stick together to help reduce any bleeding that may happen if a blood vessel is damaged. When your blood has too few platelets, mild to serious bleeding can occur inside your body (internal bleeding) or from the surface of your skin (external bleeding), especially during or after an operation.

The purpose of this research study is to:

  • test the safety and effectiveness of the study drug, avatrombopag, in subjects with thrombocytopenia undergoing an operation
  • test the effect of the study drug, avatrombopag, on the need for platelet transfusions in subjects with thrombocytopenia undergoing an operation
  • test the effect of the study drug, avatrombopag, on bleeding in subjects with thrombocytopenia undergoing an operation

This is a research study to test an investigational drug, avatrombopag.  An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA) for this treatment.

Because this is a research study, avatrombopag will be given to you only during this study and not after the study is over.

Close

Inclusion Criteria
  • Men and women greater than or equal to 18 years of age;
  • A mean baseline platelet count between:
    • 50 × 10^9/L and <100 × 10^9/L for non-chronic liver disease participants
    • 50 × 10^9/L and <75 × 10^9/L for participants with chronic liver disease;
  • Participant is scheduled to undergo operations to critical sites (eg, eye surgery, neurosurgery) or operations with a high risk of bleeding (eg, major abdominal surgery), and, in the opinion of the Investigator, would otherwise require a platelet transfusion aiming for a platelet count of at least 100 × 10^9/L to prevent bleeding

Close

Exclusion Criteria
  • Participant with a history of arterial or venous thrombosis;
  • Participant with known portal vein blood flow velocity rate <10 cm/second or previous portal vein thrombosis within 6 months of screening;
  • Participant plans to have a platelet transfusion or plans to receive blood products containing platelets within 7 days of the Screening Visit;
  • Use of anticoagulant or antiplatelet therapy;
  • Use of erythropoietin-stimulating agents;
  • Participant has a known medical history of genetic prothrombotic syndromes; or
  • Participant has abnormal hemoglobin levels or prothrombin time/international normalized ratio

Close