A Study of TAK-330 to Reverse the Effects of Factor Xa Inhibitors For Adults Needing Urgent Surgery
Start Date
8/24/2022
Completion Date
8/30/2028
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
TAK-330
SOC 4F-PCC
Conditions
Locations
University of Arkansas Medical Sciences
Arkansas City, Arkansas 72205
United States
University of California Davis Health System
Sacramento, California 95817
United States
Denver Metro Orthopedics, P.C.
Englewood, Colorado 80012
United States
University of Florida
Gainesville, Florida 32608
United States
Rutgers, The State University of New Jersey
New Brunswick, New Jersey 07103
United States
ECU Health Medical Center
Greenville, North Carolina 27858
United States
Metro Health Medical Center
Cleveland, Ohio 44109
United States
Ohio State University
Columbus, Ohio 43210
United States
Ascension St. John Medical Center
Tulsa, Oklahoma 74104
United States
University of Pennsylvania - Perelman School of Medicine
Philadelphia, Pennsylvania 19104
United States
UPMC
Pittsburgh, Pennsylvania 15213
United States
University of Texas Southwestern Medical Center
Dallas, Texas 75390
United States
Carilion Medical Center
Virginia Beach, Virginia 24014
United States
Hospital Universitario Austral
Buenos Aires, B1629WWA
Argentina
Clinica Zabala
Ciudad Autonoma Buenos Aires, 1426
Argentina
Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia - FLENI
Ciudad Autonoma Buenos Aires, CP1428
Argentina
Hospital Privado de Rosario
Santa Fe, 3000
Argentina
LKH - Universitaetsklinikum Graz
Graz, 8036
Austria
Landesklinikum Neunkirchen
Neunkirchen, 2620
Austria
ZOL
Genk, Limburg 3600
Belgium
Jessa Ziekenhuis Hospital
Hasselt, Limburg 3500
Belgium
AZ Groeninge
Kortrijk, 8500
Belgium
CHU UCL Namur
Therasse 1, 5530
Belgium
Irmandade da Santa Casa da Misericordia de Santos
Santos, São Paulo 11010-000
Brazil
Hospital de Clinicas de Ijui
Ijuí, 98700-000
Brazil
Hospital Sao Paulo
São Paulo, 5102
Brazil
Hamilton General Hospital
Hamilton, Ontario L8L 2X2
Canada
London Health Sciences Centre (LHSC) - University Hospital
London, Ontario N6A 5A5
Canada
Unity Health Toronto St Michaels Hospital
Toronto, Ontario M5N 1W8
Canada
Montreal General Hospital
Montreal, Quebec H3G 1A4
Canada
The Ottawa Hospital - General Campus
Ontario, K1H 8L6
Canada
CHU de Quebec- Hopital de l Enfant Jesus
Québec, G1J-1Z4
Canada
Fakultni nemocnice Brno
Jihlavska, 625 00
Czechia
Fakultni nemocnice v Motole
Prague (Praha), 15000
Czechia
Dept of II. interni klinika - gastroenterologie
Srobarova C, 100 34
Czechia
CHU Strasbourg - Hopital Hautepierre
Strasbourg, Bas Rhin 67098
France
Hospital michallon - CHUGA
Grenoble, 38043
France
Hopital Marie Lannelongue
Le Plessis-Robinson, 92350
France
Hôpital Lariboisière
Paris, 75010
France
GH Paris Saint Joseph
Paris, 75014
France
BG Klinikum Murnau gGmbH
Murnau am Staffelsee, Bavaria 82418
Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, Saxony 01307
Germany
Universitaetsklinikum Leipzig AoeR
Leipzig, Saxony 04103
Germany
Klinikum Dortmund gGmbH
Murnau am Staffelsee, 44137
Germany
Konstantopoulio General Hospital, N.Ionia
Nea Ionia, Attica 14233
Greece
Bekes Varmegyei Kozponti Korhaz
Békéscsaba, Attica 5700
Hungary
Ozdi Almasi Balogh Pal Korhaz
Szeged, Attica 6725
Hungary
Semmelweis Egyetem
Budapest, 1082
Hungary
Debreceni Egyetem
Debrecen, 4032
Hungary
Shamir Medical Center (Assaf Harofe)
Beer Yaacov, 70300
Israel
Soroka Medical Center
Beersheba, 8410101
Israel
Rambam Health Care Campus
Haifa, 3109601
Israel
Shaare Zedek Medical Center
Jerusalem, 9103102
Israel
Hadassah University Hospital - Ein Kerem
Jerusalem, 911200
Israel
Rabin MC
Petah Tikva, 49100
Israel
Chaim Sheba Medical Center
Ramat Gan, 5265601
Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
Israel
Uniwersytecki Szpital Kliniczny nr 1 im. prof. Tadeusza Sokołowskiego PUM w Szczecinie
Szczecin, 71-252
Poland
Centro Hospitalar do Baixo Vouga, E.P.E. - Unidade de Aveiro
Aveiro, 3810-501
Portugal
Centro Hospitalar do Baixo Vouga, E.P.E. - Unidade de Aveiro
Aveiro, 3814-501
Portugal
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E
Rua Conceição Fernandes, 4434-502
Portugal
Hospital Clinico Universitario de Salamanca
Salamnca, Salamanca 37007
Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010
Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Spain