Actively Recruiting
A Phase 3 Trial Evaluating TAK-330 Versus Standard 4F-PCC for Reversing Factor Xa Inhibitor Anticoagulation in Adults Needing Urgent Surgery
Led by Takeda · Updated on 2026-01-28
328
Participants Needed
64
Research Sites
N/A
Total Duration
On this page
Sponsors
T
Takeda
Lead Sponsor
T
Takeda Development Center Americas, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of TAK-330 compared with a standard treatment known as four-factor prothrombin complex concentrate (4F-PCC) for reversing anticoagulation caused by Factor Xa inhibitors in adults needing urgent surgery or invasive procedures. This Phase 3 trial aims to determine which treatment better controls bleeding during and after surgery in patients who require rapid reversal of blood thinning effects. Participants will be randomly assigned to receive either TAK-330 or the standard 4F-PCC treatment before surgery. TAK-330 is given as a single intravenous infusion of 25 international units per kilogram on the day of surgery, with an optional additional dose during surgery if needed, not exceeding a total dose of 50 IU/kg or 5,000 IU. The standard 4F-PCC is administered according to local protocols, with a possible additional dose during surgery under similar dosing limits. During the study, patients will be hospitalized and monitored closely. Researchers will assess bleeding control during surgery, blood product use, and adverse events up to 30 days after surgery. Follow-up contact will be conducted by phone or telehealth 30 days post-surgery. The main outcome measured is the percentage of participants achieving effective bleeding control at the end of surgery.
CONDITIONS
Brief Title
A Study of TAK-330 to Reverse the Effects of Factor Xa Inhibitors For Adults Needing Urgent Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant or legally authorized representative willing to sign informed consent.
- Adults aged 18 years or older at enrollment.
- Currently treated with oral Factor Xa inhibitors (rivaroxaban, apixaban, edoxaban).
- Requires urgent surgery or invasive procedure within 15 hours of last Factor Xa inhibitor dose with high bleeding risk, or has elevated anti-Factor Xa levels if beyond 15 hours.
- Women of childbearing potential must have a negative pregnancy test before enrollment.
You will not qualify if you...
- Expected survival less than 30 days despite medical care.
- Recent (within 90 days) venous thromboembolism, myocardial infarction, disseminated intravascular coagulation, stroke, transient ischemic attack, unstable angina, or severe COVID-19 infection.
- Active major bleeding requiring surgery or transfusion of more than 2 units of red blood cells, or intracranial hemorrhage except certain subdural hemorrhages.
- Polytrauma where reversal of Factor Xa inhibition alone is insufficient.
- Known prothrombotic or bleeding disorders.
- Platelet count less than 50,000 per microliter.
- History of heparin-induced thrombocytopenia.
- Use of certain procoagulant drugs or blood products within 7 days before enrollment.
- Planned use of these drugs or products before 24-hour hemostatic assessment after enrollment.
- Use of unfractionated heparin within 2 hours or low molecular weight heparin within 6 hours before randomization.
- Hypersensitivity to study drugs or components.
- History of IgA deficiency with hypersensitivity.
- Septic shock with persistent low blood pressure and high lactate.
- Severe liver failure (Child-PUGH score C).
- Renal failure requiring dialysis.
- Any condition posing undue risk per investigator judgment.
- Participation in other investigational studies within 30 days.
- Use of PROTHROMPLEX TOTAL as standard care 4F-PCC.
- Women breastfeeding at enrollment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day 1 and during surgery as required
Participants receive either TAK-330 or standard 4F-PCC as a single intravenous infusion before urgent surgery, with an additional dose possible during surgery if needed.
1 to 2 visits on Day 1 and during surgery
Duration - Up to 30 days after surgery
Participants are monitored for safety and effectiveness outcomes including bleeding control and adverse events after surgery.
Approximately 1 visit within 30 days post-surgery
Trial Site Locations
Total: 64 locations
1
University of Arkansas Medical Sciences
Arkansas City, Arkansas, United States, 72205
Actively Recruiting
2
University of California Davis Health System
Sacramento, California, United States, 95817
Actively Recruiting
3
Denver Metro Orthopedics, P.C.
Englewood, Colorado, United States, 80012
Actively Recruiting
4
University of Florida
Gainesville, Florida, United States, 32608
Actively Recruiting
5
Rutgers, The State University of New Jersey
New Brunswick, New Jersey, United States, 07103
Actively Recruiting
6
ECU Health Medical Center
Greenville, North Carolina, United States, 27858
Actively Recruiting
7
Metro Health Medical Center
Cleveland, Ohio, United States, 44109
Actively Recruiting
8
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
9
Ascension St. John Medical Center
Tulsa, Oklahoma, United States, 74104
Actively Recruiting
10
University of Pennsylvania - Perelman School of Medicine
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
11
UPMC
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
12
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
13
Carilion Medical Center
Virginia Beach, Virginia, United States, 24014
Actively Recruiting
14
Hospital Universitario Austral
Buenos Aires, Argentina, B1629WWA
Actively Recruiting
15
Clinica Zabala
Ciudad Autonoma Buenos Aires, Argentina, 1426
Actively Recruiting
16
Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia - FLENI
Ciudad Autonoma Buenos Aires, Argentina, CP1428
Actively Recruiting
17
Hospital Privado de Rosario
Santa Fe, Argentina, 3000
Actively Recruiting
18
LKH - Universitaetsklinikum Graz
Graz, Austria, 8036
Actively Recruiting
19
Landesklinikum Neunkirchen
Neunkirchen, Austria, 2620
Actively Recruiting
20
ZOL
Genk, Limburg, Belgium, 3600
Actively Recruiting
21
Jessa Ziekenhuis Hospital
Hasselt, Limburg, Belgium, 3500
Actively Recruiting
22
AZ Groeninge
Kortrijk, Belgium, 8500
Actively Recruiting
23
CHU UCL Namur
Therasse 1, Belgium, 5530
Actively Recruiting
24
Irmandade da Santa Casa da Misericordia de Santos
Santos, São Paulo, Brazil, 11010-000
Actively Recruiting
25
Hospital de Clinicas de Ijui
Ijuí, Brazil, 98700-000
Actively Recruiting
26
Hospital Sao Paulo
São Paulo, Brazil, 5102
Actively Recruiting
27
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Actively Recruiting
28
London Health Sciences Centre (LHSC) - University Hospital
London, Ontario, Canada, N6A 5A5
Actively Recruiting
29
Unity Health Toronto St Michaels Hospital
Toronto, Ontario, Canada, M5N 1W8
Actively Recruiting
30
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Actively Recruiting
31
The Ottawa Hospital - General Campus
Ontario, Canada, K1H 8L6
Actively Recruiting
32
CHU de Quebec- Hopital de l Enfant Jesus
Québec, Canada, G1J-1Z4
Actively Recruiting
33
Fakultni nemocnice Brno
Jihlavska, Czechia, 625 00
Actively Recruiting
34
Fakultni nemocnice v Motole
Prague (Praha), Czechia, 15000
Actively Recruiting
35
Dept of II. interni klinika - gastroenterologie
Srobarova C, Czechia, 100 34
Actively Recruiting
36
CHU Strasbourg - Hopital Hautepierre
Strasbourg, Bas Rhin, France, 67098
Actively Recruiting
37
Hospital michallon - CHUGA
Grenoble, France, 38043
Completed
38
Hopital Marie Lannelongue
Le Plessis-Robinson, France, 92350
Completed
39
Hôpital Lariboisière
Paris, France, 75010
Completed
40
GH Paris Saint Joseph
Paris, France, 75014
Actively Recruiting
41
BG Klinikum Murnau gGmbH
Murnau am Staffelsee, Bavaria, Germany, 82418
Actively Recruiting
42
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, Saxony, Germany, 01307
Actively Recruiting
43
Universitaetsklinikum Leipzig AoeR
Leipzig, Saxony, Germany, 04103
Actively Recruiting
44
Klinikum Dortmund gGmbH
Murnau am Staffelsee, Germany, 44137
Actively Recruiting
45
Konstantopoulio General Hospital, N.Ionia
Nea Ionia, Attica, Greece, 14233
Actively Recruiting
46
Bekes Varmegyei Kozponti Korhaz
Békéscsaba, Attica, Hungary, 5700
Actively Recruiting
47
Ozdi Almasi Balogh Pal Korhaz
Szeged, Attica, Hungary, 6725
Actively Recruiting
48
Semmelweis Egyetem
Budapest, Hungary, 1082
Actively Recruiting
49
Debreceni Egyetem
Debrecen, Hungary, 4032
Actively Recruiting
50
Shamir Medical Center (Assaf Harofe)
Beer Yaacov, Israel, 70300
Actively Recruiting
51
Soroka Medical Center
Beersheba, Israel, 8410101
Actively Recruiting
52
Rambam Health Care Campus
Haifa, Israel, 3109601
Actively Recruiting
53
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Actively Recruiting
54
Hadassah University Hospital - Ein Kerem
Jerusalem, Israel, 911200
Actively Recruiting
55
Rabin MC
Petah Tikva, Israel, 49100
Actively Recruiting
56
Chaim Sheba Medical Center
Ramat Gan, Israel, 5265601
Actively Recruiting
57
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 6423906
Actively Recruiting
58
Uniwersytecki Szpital Kliniczny nr 1 im. prof. Tadeusza Sokołowskiego PUM w Szczecinie
Szczecin, Poland, 71-252
Actively Recruiting
59
Centro Hospitalar do Baixo Vouga, E.P.E. - Unidade de Aveiro
Aveiro, Portugal, 3810-501
Actively Recruiting
60
Centro Hospitalar do Baixo Vouga, E.P.E. - Unidade de Aveiro
Aveiro, Portugal, 3814-501
Actively Recruiting
61
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E
Rua Conceição Fernandes, Portugal, 4434-502
Actively Recruiting
62
Hospital Clinico Universitario de Salamanca
Salamnca, Salamanca, Spain, 37007
Actively Recruiting
63
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
64
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Actively Recruiting
Research Team
T
Takeda Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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