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NCT05156983 · ClinicalTrials.gov registry record · Phase 3
A Study of TAK-330 to Reverse the Effects of Factor Xa Inhibitors For Adults Needing Urgent Surgery
A Phase 3 study of Coagulation Disorder, sponsored by Takeda.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 328
- Enrollment target
- 20
- Study locations
NCT05156983: Recruiting Phase 3 study of Coagulation Disorder, sponsored by Takeda.
NCT05156983 is a Phase 3 study of Coagulation Disorder that is actively recruiting participants, run by Takeda. The registered enrollment target is 328 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05156983, a Phase 3 study of Coagulation Disorder, is actively recruiting participants, sponsored by Takeda.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 328 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Percentage of participants achieving intraoperative effective hemostasis, as determined by the Intraoperative Four Point Hemostatic Efficacy Scale and assessed by the principal investigator (PI), the surgeon, or a qualified member of the surgical team.
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 |
What NCT05156983 shows while recruiting
NCT05156983 is an interventional study that assigns participants to a tested intervention. The registered 328 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower).
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.
NCT05156983 names 20 study sites across 13 states, led by Other, Ohio, Pennsylvania.
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.
What interventions are being tested in trial NCT05156983?
The interventions under investigation include: TAK-330 (DRUG), SOC 4F-PCC (DRUG).
Who is sponsoring clinical trial NCT05156983?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Coagulation Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05156983's enrollment target sits among peer trials
328 1075th of 2000 higher than 926 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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