A Study of TAK-330 to Reverse the Effects of Factor Xa Inhibitors For Adults Needing Urgent Surgery

Inclusion Criteria:

• Participant or legally authorized representative willing to sign e-consent/writteninformed 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/procedurethat is associated with high-risk of intraoperative bleeding within 15 hours fromthe last dose of Factor Xa inhibitor and requires a reversal agent for suspecteddirect oral Factor Xa inhibitor-related coagulopathy. For participants who arebeyond the 15-hour window, eligibility requires proof of elevated plasma anti-FactorXa (FXa) levels using either specific direct oral anti-coagulant (DOAC)-calibrated (apixaban, rivaroxaban or edoxaban) anti-FXa levels of greater than (>) 75 nanogramsper milliliter (ng/mL), or heparin calibrated anti-FXa assay levels of >0.5international unit per milliliter (IU/mL) at screening.

• Women of childbearing potential should have a negative pregnancy test documentedprior to enrollment.

Exclusion Criteria:

• The participant has an expected survival of less than 30 days, even with bestavailable medical and surgical care.

• Recent history (within 90 days prior to screening) of venous thromboembolism,myocardial infarction (MI), disseminated intravascular coagulation (DIC), ischemicstroke, transient ischemic attack, hospitalization for unstable angina pectoris orsevere or critical coronavirus 2 (SARS-CoV-2) infection.

• Active major bleeding defined as bleeding that requires surgery or transfusion of >2units of packed red blood cell (PRBC) or intracranial hemorrhage with the exceptionof subacute and chronic subdural hemorrhages with a Glasgow Coma Score (GCS) greaterthan or equal to (>=) 9.

• Polytrauma for which reversal of Factor Xa-inhibition alone would not be sufficientto achieve hemostasis.

• Known prothrombotic disorder including primary antiphospholipid syndrome,antithrombin-3 deficiency, homozygous protein C deficiency, homozygous protein Sdeficiency, and homozygous factor V Leiden.

• Known bleeding disorder (example, platelet function disorders, hemophilia, VonWillebrand disease, or coagulation factor deficiency).

• Platelet count less than (<) 50,000 per microliter (/mcL).

• History of heparin-induced thrombocytopenia.

• Administration of procoagulant drugs (example, non-study prothrombin complexconcentrates (PCCs), recombinant Factor VIIa) or blood products (transfusion ofwhole blood, fresh frozen plasma, cryoglobulins, plasma fractions, or platelets)within 7 days before enrollment. (Note: administration of PRBCs for hemoglobincorrection, tranexamic acid or aminocaproic acid are not exclusion criteria).

• Planned use of procoagulant drugs (example, Vitamin K, non-study PCCs, recombinantFactor VIIa) or blood products (transfusion of whole blood, fresh frozen plasma,cryoglobulins, plasma fractions, or platelets) after enrollment but before the 24±4hours hemostatic assessment (Key secondary endpoint). Planned administration oftranexamic acid (TXA) or aminocaproic acid after randomization but before the startof IP infusion, should be noted during randomization to properly stratify theseparticipants in the interactive response technology (IRT). Planned administration ofTXA or aminocaproic acid after start of IP infusion but before the 24±4 hourshemostatic assessment is prohibited. Administration of any of the above productsbefore the 24±4 hours hemostatic assessment will impact the assessment ofhemostasis. Administration of PRBCs for hemoglobin correction, is not an exclusioncriterion.

• Administration of unfractionated heparin within 2 hours before randomization or lowmolecular 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 withhypersensitivity reaction and antibodies to IgA.

• Septic shock as defined by persistent hypotension requiring vasopressors to maintainmean arterial pressure (MAP) >=65 millimeters of mercury (mmHg) and having bloodlactate >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 theparticipant at undue risk of harm if the participant were to participate in thestudy.

• Participation in another clinical study involving an investigational product ordevice within 30 days prior to study enrollment, or planned participation in anotherclinical study involving an investigational product or device during the course ofthis 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.