Actively Recruiting
A Phase 3 Trial Evaluating TAK-330 Versus Standard 4F-PCC for Reversing Factor Xa Inhibitor Anticoagulation in Adults Needing Urgent Surgery
Led by Takeda · Updated on 2026-01-28
328
Participants Needed
64
Research Sites
N/A
Total Duration
On this page
Sponsors
T
Takeda
Lead Sponsor
T
Takeda Development Center Americas, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of TAK-330 compared with a standard treatment known as four-factor prothrombin complex concentrate 4F-PCC for reversing anticoagulation caused by Factor Xa inhibitors in adults needing urgent surgery or invasive procedures. This Phase 3 trial aims to determine which treatment better controls bleeding during and after surgery in patients who require rapid reversal of blood thinning effects. Participants will be randomly assigned to receive either TAK-330 or the standard 4F-PCC treatment before surgery. TAK-330 is given as a single intravenous infusion of 25 international units per kilogram on the day of surgery, with an optional additional dose during surgery if needed, not exceeding a total dose of 50 IUkg or 5,000 IU. The standard 4F-PCC is administered according to local protocols, with a possible additional dose during surgery under similar dosing limits. During the study, patients will be hospitalized and monitored closely. Researchers will assess bleeding control during surgery, blood product use, and adverse events up to 30 days after surgery. Follow-up contact will be conducted by phone or telehealth 30 days post-surgery. The main outcome measured is the percentage of participants achieving effective bleeding control at the end of surgery.
CONDITIONS
Brief Title
A Study of TAK-330 to Reverse the Effects of Factor Xa Inhibitors For Adults Needing Urgent Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant or legally authorized representative willing to sign informed consent.
- Adults aged 18 years or older at enrollment.
- Currently treated with oral Factor Xa inhibitors (rivaroxaban, apixaban, edoxaban).
- Requires urgent surgery or invasive procedure within 15 hours of last Factor Xa inhibitor dose with high bleeding risk, or has elevated anti-Factor Xa levels if beyond 15 hours.
- Women of childbearing potential must have a negative pregnancy test before enrollment.
You will not qualify if you...
- Expected survival less than 30 days despite medical care.
- Recent (within 90 days) venous thromboembolism, myocardial infarction, disseminated intravascular coagulation, stroke, transient ischemic attack, unstable angina, or severe COVID-19 infection.
- Active major bleeding requiring surgery or transfusion of more than 2 units of red blood cells, or intracranial hemorrhage except certain subdural hemorrhages.
- Polytrauma where reversal of Factor Xa inhibition alone is insufficient.
- Known prothrombotic or bleeding disorders.
- Platelet count less than 50,000 per microliter.
- History of heparin-induced thrombocytopenia.
- Use of certain procoagulant drugs or blood products within 7 days before enrollment.
- Planned use of these drugs or products before 24-hour hemostatic assessment after enrollment.
- Use of unfractionated heparin within 2 hours or low molecular weight heparin within 6 hours before randomization.
- Hypersensitivity to study drugs or components.
- History of IgA deficiency with hypersensitivity.
- Septic shock with persistent low blood pressure and high lactate.
- Severe liver failure (Child-PUGH score C).
- Renal failure requiring dialysis.
- Any condition posing undue risk per investigator judgment.
- Participation in other investigational studies within 30 days.
- Use of PROTHROMPLEX TOTAL as standard care 4F-PCC.
- Women breastfeeding at enrollment.
Research Team
T
Takeda Contact
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