Phase 3 Trial of TAK-330 for Reversal of Direct Oral Factor Xa Inhibitor-induced Anticoagulation
The Reverser Study is for patients on blood thinners who need emergency surgery.
About
The Reverser Study is a clinical research study evaluating an investigational drug that may help control bleeding in patients on blood thinners who need emergency surgery. In the study, the investigational drug will be compared to the standard-of-care therapy used to reverse the effects of blood thinners. All participants will receive either the investigational drug or standard-of-care therapy.
Eligibility Criteria
Inclusion Criteria:
- Adults >18 years
- Currently taking an oral factor Xa inhibitor such as rivaroxaban, apixaban, or edoxaban
- High-risk surgery within 15 hours of last dose, or while anti-Xa level is elevated
- Negative pregnancy test for women of childbearing potential
Exclusion Criteria:
- Life expectancy <30 days
- Recent (<90 days) venous thromboembolism, myocardial infarction, stroke, sepsis, or severe COVID-19
- Polytrauma or other bleeding disorders
- History of heparin induced thrombocytopenia or platelet count <50,000/μL
Primary Investigator
Dr. Bower is an Acute Care Surgeon with more than 20 years of clinical and research experience. She is an associate professor at the Virginia Tech Carilion School of Medicine. She is board certified by the American Board of Surgery and the American Board of Internal Medicine in General Surgery, Surgical Critical Care, and Hospice and Palliative Medicine. She completed her Trauma and Surgical Critical Care fellowship and master's degree in clinical research science at the University of Louisville, her Hospice and Palliative Medicine fellowship at Virginia Tech Carilion School of Medicine – Carilion Clinic, completed her internship, residency at East Carolina University, and her Doctor of Medicine at University of Buffalo.
Contact Information
Sydney Webb, MPH, CPP
Research Director, Surgery