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A Study of TAK-330 to Reverse the Effects of Factor Xa Inhibitors For Adults Needing Urgent Surgery
NCT05156983 · View on ClinicalTrials.gov ↗
Study Summary
The aim of this study is to find out the effects of TAK-330 compared with four-factor prothrombin complex concentrate (4F-PCC) as part of standard treatment other than Prothromplex Total for anticoagulation reversal in participants treated with Factor Xa inhibitors who require urgent surgery/invasive procedure. The participant will be assigned by chance to either TAK-330 or SOC 4F-PCC as part of standard treatment before surgery. Patients participating in this study will need to be hospitalized. They will also be contacted (via telehealth/phone call) 30 days after the surgery.
Conditions Studied
Interventions
- DRUG TAK-330
- DRUG SOC 4F-PCC
Study Locations (20)
Other
- Hospital Universitario Austral — Buenos Aires
- Clinica Zabala — Ciudad Autonoma Buenos Aires
- Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia - FLENI — Ciudad Autonoma Buenos Aires
- Hospital Privado de Rosario — Santa Fe
- LKH - Universitaetsklinikum Graz — Graz
- Landesklinikum Neunkirchen — Neunkirchen
Ohio
- Metro Health Medical Center — Cleveland
- Ohio State University — Columbus
Pennsylvania
- University of Pennsylvania - Perelman School of Medicine — Philadelphia
- UPMC — Pittsburgh
Arkansas
- University of Arkansas Medical Sciences — Arkansas City
California
- University of California Davis Health System — Sacramento
Colorado
- Denver Metro Orthopedics, P.C. — Englewood
Florida
- University of Florida — Gainesville
New Jersey
- Rutgers, The State University of New Jersey — New Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 328 participants |
| Start Date | 2022-08-24 |
| Est. Completion | 2028-04-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05156983
The ClinicalTrials.gov registry entry for NCT05156983 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 328 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 387 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Coagulation Disorder appearing as the primary indexed condition, and to 2 interventions — of which TAK-330 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05156983 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, Ohio, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05156983 about?
NCT05156983 is a clinical study titled "A Study of TAK-330 to Reverse the Effects of Factor Xa Inhibitors For Adults Needing Urgent Surgery". The aim of this study is to find out the effects of TAK-330 compared with four-factor prothrombin complex concentrate (4F-PCC) as part of standard treatment other than Prothromplex Total for anticoagulation reversal in participants treated with Factor Xa inhibitors who require urgent surgery/invasiv...
What is the current status of trial NCT05156983?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 328 participants. The study started on 2022-08-24. Estimated completion is 2028-04-12.
What conditions does trial NCT05156983 study?
This clinical trial studies the following conditions: Coagulation Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05156983?
The interventions under investigation include: TAK-330 (DRUG), SOC 4F-PCC (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05156983?
This trial is sponsored by Takeda, which has 387 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05156983 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Florida, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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