Comparing TAK-330 with SOC 4F-PCC for coagulation disorder

Exclusion

• −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.
• −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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →) 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.
• −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.
• −Administration of procoagulant drugs (example, non-study prothrombin complex concentrates (PCCs), recombinant Factor VIIa) or blood products (transfusion of whole blood, fresh frozen plasma, cryoglobulins, plasma fractions, or platelets) within 7 days before enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →. (Note: administration of PRBCs for hemoglobin correction, tranexamic acid or aminocaproic acid are not exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →).
• −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 endpointSecondary endpointAdditional things measured alongside the main question.Read more →). Planned administration of tranexamic acid (TXA) or aminocaproic acid after randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → 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.
• −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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, 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 studyObservational studyA study that watches what happens without assigning any treatment.Read more → is not an exclusion criterion.
• −The use of PROTHROMPLEX TOTAL as SOCStandard of careThe treatment normally given for a condition outside a study.Read more → 4F-PCC.
• −Women who are breastfeeding at the time of enrollment.
• −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.