A Study of TAK-330 for Reversing Blood Thinners Before Urgent Surgery
This study is looking at how well TAK-330 works compared to a standard treatment called 4F-PCC (four-factor prothrombin complex concentrate) for people who are taking certain blood thinners (Factor Xa inhibitors like rivaroxaban, apixaban, or edoxaban) and need urgent surgery. The goal is to see if these treatments can effectively stop bleeding during surgery. You would be randomly assigned to receive either TAK-330 or 4F-PCC before your surgery. The study plans to enroll about 440 adults aged 18 or older. The main thing researchers will measure is how well bleeding is controlled during the surgery. The current status of this study is unclear.
- Study design
- This is an interventional study where participants will be randomly assigned to receive either TAK-330 or SOC 4F-PCC. It plans to enroll about 440 participants.
- What's involved
- You will need to be hospitalized for the study. You will also have a follow-up contact via telehealth or phone call 30 days after your surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be contacted 30 days after the surgery via telehealth or phone call.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05156983
A Study of TAK-330 to Reverse the Effects of Factor Xa Inhibitors For Adults Needing Urgent Surgery
Recruiting
PHASE3Ages 18+InterventionalTreatmentTakeda
~440 participants
Updated 2026-06-18 on ClinicalTrials.gov
What's tested:TAK-330SOC 4F-PCC
At a glance
Recruiting sites
61 of 64 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants With Intraoperative Effective Hemostasis
Measured over At the end of the surgery/procedure
Conditions
Where it's being run
64 sites across 33 statesIsrael8
Argentina4
France4
Ontario3
Czechia3
Attica3
Portugal3
Ohio2
Study leadership
- Study Director · STUDY_DIRECTOR · Takeda
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Participant or legally authorized representative willing to sign e-consent/written informed consent form.
Participants at least 18 years of age at enrollment.
Participant currently on treatment with oral Factor Xa inhibitor (rivaroxaban, apixaban, edoxaban).
In the opinion of the surgeon, the participant requires an urgent surgery/procedure that is associated with high-risk of intraoperative bleeding within 15 hours from the last dose of Factor Xa inhibitor and requires a reversal agent for suspected direct oral Factor Xa inhibitor-related coagulopathy. For participants who are beyond the 15-hour window, eligibility requires proof of elevated plasma anti-Factor Xa (FXa) levels using either specific direct oral anti-coagulant (DOAC)-calibrated (apixaban, rivaroxaban or edoxaban) anti-FXa levels of greater than (\>) 75 nanograms per milliliter (ng/mL), or heparin calibrated anti-FXa assay levels of \>0.5 international unit per milliliter (IU/mL) at screening.
Women of childbearing potential should have a negative pregnancy test documented prior to enrollment.
Exclusion
The participant has an expected survival of less than 30 days, even with best available medical and surgical care.
Recent history (within 90 days prior to screening) of venous thromboembolism, myocardial infarction (MI), disseminated intravascular coagulation (DIC), ischemic stroke, transient ischemic attack, hospitalization for unstable angina pectoris or severe or critical coronavirus 2 (SARS-CoV-2) infection.
Active major bleeding defined as bleeding that requires surgery or transfusion of \>2 units of packed red blood cell (PRBC) or intracranial hemorrhage with the exception of subacute and chronic subdural hemorrhages with a Glasgow Coma Score (GCS) greater than or equal to (\>=) 9.
Polytrauma for which reversal of Factor Xa-inhibition alone would not be sufficient to achieve hemostasis.
Known prothrombotic disorder including primary antiphospholipid syndrome, antithrombin-3 deficiency, homozygous protein C deficiency, homozygous protein S deficiency, and homozygous factor V Leiden.
Known bleeding disorder (example, platelet function disorders, hemophilia, Von Willebrand disease, or coagulation factor deficiency).
Platelet count less than (\<) 50,000 per microliter (/mcL).
History of heparin-induced thrombocytopenia.
Planned use of procoagulant drugs (example, Vitamin K, non-study PCCs, recombinant Factor VIIa) or blood products (transfusion of whole blood, fresh frozen plasma, cryoglobulins, plasma fractions, or platelets) after enrollment but before the 24±4 hours hemostatic assessment (Key secondary endpoint). Planned administration of tranexamic acid (TXA) or aminocaproic acid after randomization but before the start of IP infusion, should be noted during randomization to properly stratify these participants in the interactive response technology (IRT). Planned administration of TXA or aminocaproic acid after start of IP infusion but before the 24±4 hours hemostatic assessment is prohibited. Administration of any of the above products before the 24±4 hours hemostatic assessment will impact the assessment of hemostasis. Administration of PRBCs for hemoglobin correction, is not an exclusion criterion.
Administration of unfractionated heparin within 2 hours before randomization or low molecular weight heparin within 6 hours before randomization.
Hypersensitivity to PCC constituents or any excipient of TAK-330.
Participants with history of confirmed immunoglobulin A (IgA) deficiency with hypersensitivity reaction and antibodies to IgA.
Septic shock as defined by persistent hypotension requiring vasopressors to maintain mean arterial pressure (MAP) \>=65 millimeters of mercury (mmHg) and having blood lactate \>2 millimole (mmol) despite adequate volume resuscitation.
Acute or chronic liver failure (hepatic cirrhosis Child-PUGH score C)
Renal failure requiring dialysis
Any other condition that could, in the opinion of the investigator, put the participant at undue risk of harm if the participant were to participate in the study.
Participation in another clinical study involving an investigational product or device within 30 days prior to study enrollment, or planned participation in another clinical study involving an investigational product or device during the course of this study. Participation in an observational study is not an exclusion criterion.
The use of PROTHROMPLEX TOTAL as SOC 4F-PCC.
Women who are breastfeeding at the time of enrollment.
What this trial measures
- Percentage of Participants With Intraoperative Effective HemostasisAt the end of the surgery/procedure
Percentage of participants achieving intraoperative effective hemostasis, as determined by the Intraoperative Four Point Hemostatic Efficacy Scale and assessed by the principal investigator (PI), the surgeon, or a qualified member of the surgical team.