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Using TAK-330 to reverse blood thinning effects for urgent surgeries

A Phase 3, Prospective, Randomized, Open-label, Adaptive Group Sequential, Multicenter Trial With Blinded Endpoint Assessment to Evaluate the Efficacy and Safety of TAK-330 for the Reversal of Direct Oral Factor Xa Inhibitor-induced Anticoagulation in Patients Requiring Urgent Surgery/Invasive Procedure

PHASE3 · Takeda · NCT05156983

This study is testing if a new drug called TAK-330 can work better than a standard treatment to reverse blood thinning effects for adults who need urgent surgery.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment328 (estimated)
Ages18 Years and up
SexAll
SponsorTakeda (industry)
Locations64 sites (Arkansas City, Arkansas and 63 other locations)
Trial IDNCT05156983 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of TAK-330 compared to standard treatment with four-factor prothrombin complex concentrate (4F-PCC) for reversing the effects of Factor Xa inhibitors in adults who need urgent surgery. Participants will be randomly assigned to receive either TAK-330 or 4F-PCC before their surgical procedure. The study aims to determine which treatment is more effective in managing coagulopathy related to Factor Xa inhibitors. Patients will be monitored for 30 days post-surgery to assess outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are currently on oral Factor Xa inhibitors and require urgent surgery within 15 hours of their last dose.

Not a fit: Patients who are not on Factor Xa inhibitors or do not require urgent surgical intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve surgical outcomes for patients on Factor Xa inhibitors by effectively reversing anticoagulation.

How similar studies have performed: Other studies have shown promise in reversing anticoagulation effects, but this specific approach with TAK-330 is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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.
* 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 enrollment. (Note: administration of PRBCs for hemoglobin correction, tranexamic acid or aminocaproic acid are not exclusion criteria).
* 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.

Where this trial is running

Arkansas City, Arkansas and 63 other locations

+14 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Coagulation Disorder, Reversal of Factor Xa inhibitors

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.