A Study of TAK-330 to Reverse the Effects of Factor Xa Inhibitors For Adults Needing Urgent Surgery
Public ClinicalTrials.gov record NCT05156983. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05156983
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 440 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 23, 2022
- Primary completion
- Aug 29, 2028
- Completion
- Aug 29, 2028
- Last update posted
- Jun 17, 2026
2022 – 2028
United States locations
- U.S. sites
- 13
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arkansas Medical Sciences | Arkansas City | Arkansas | 72205 | Recruiting |
| University of California Davis Health System | Sacramento | California | 95817 | Recruiting |
| Denver Metro Orthopedics, P.C. | Englewood | Colorado | 80012 | Recruiting |
| University of Florida | Gainesville | Florida | 32608 | Recruiting |
| Rutgers, The State University of New Jersey | New Brunswick | New Jersey | 07103 | Recruiting |
| ECU Health Medical Center | Greenville | North Carolina | 27858 | Recruiting |
| Metro Health Medical Center | Cleveland | Ohio | 44109 | Recruiting |
| Ohio State University | Columbus | Ohio | 43210 | Recruiting |
| Ascension St. John Medical Center | Tulsa | Oklahoma | 74104 | Recruiting |
| University of Pennsylvania - Perelman School of Medicine | Philadelphia | Pennsylvania | 19104 | Recruiting |
| UPMC | Pittsburgh | Pennsylvania | 15213 | Recruiting |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | Recruiting |
| Carilion Medical Center | Virginia Beach | Virginia | 24014 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 51 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05156983, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 17, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05156983 live on ClinicalTrials.gov.