A Study of TAK-330 to Reverse the Effects of Factor Xa Inhibitors For Adults Needing Urgent Surgery

PHASE3RecruitingINTERVENTIONAL
Enrollment

328

Participants

Timeline

Start Date

August 24, 2022

Primary Completion Date

April 12, 2028

Study Completion Date

April 12, 2028

Conditions
Coagulation Disorder
Interventions
DRUG

TAK-330

Participants will receive TAK-330, 25 IU/kg single intravenous infusion on Day 1 and an additional dose of 25 IU/kg TAK-330 can be administered if required.

DRUG

SOC 4F-PCC

Participants will receive 4F-PCC as SOC on Day 1. The dose and infusion speed of the SOC 4F-PCC will be based on local institutional protocols. An additional dose of SOC 4F-PCC not exceeding total dose of 50 IU/kg or 5,000 IU, whichever is smaller can be given during the surgery if required.

Trial Locations (49)

1090

RECRUITING

Universitair Ziekenhuis Brussel, Jette

2620

RECRUITING

Landesklinikum Neunkirchen, Neunkirchen

3000

RECRUITING

UZ Leuven, Leuven

3500

RECRUITING

Jessa Ziekenhuis Hospital, Hasselt

3600

RECRUITING

ZOL, Genk

5280

RECRUITING

KH St.Josef Braunau am Inn, Braunau am Inn

5530

RECRUITING

CHU UCL Namur, Yvoir

6229

COMPLETED

Maastricht University Medical Center , Department of Anesthesiology & Pain Management, Maastricht

8036

RECRUITING

LKH - Universitaetsklinikum Graz, Graz

10595

RECRUITING

Westchester Medical College, Valhalla

15213

RECRUITING

UPMC, Pittsburgh

19104

RECRUITING

University of Pennsylvania - Perelman School of Medicine, Philadelphia

20010

RECRUITING

MedStar Washington Hospital Center - Washington Cancer Institute (WCI), Washington D.C.

27834

RECRUITING

ECU Health Medical Center, Greenville

31059

RECRUITING

CHU Toulouse - Hopital Rangueil, Toulouse

32608

RECRUITING

University of Florida, Gainesville

33136

RECRUITING

Jackson Memorial Hospital, University of Miami, Miami

RECRUITING

University of Miami - Miller School of Medicine, Miami

37007

RECRUITING

Hospital Clinico Universitario de Salamanca, Salamnca

38043

COMPLETED

Hospital michallon - CHUGA, Grenoble

40202

RECRUITING

University of Louisville School of Medicine, Louisville

43210

RECRUITING

Ohio State University, Columbus

44109

RECRUITING

Metro Health Medical Center, Cleveland

46010

RECRUITING

Hospital Clinico Universitario de Valencia, Valencia

46017

RECRUITING

Hospital Universitario Dr Peset, Valencia

46026

RECRUITING

Hospital Universitari i Politecnic La Fe, Valencia

59037

RECRUITING

Hopital Cardiologique CHU Lille, Lille

63000

RECRUITING

CHU Clermont Ferrand - Hopital Gabriel Montpied, Clermont-Ferrand

67098

RECRUITING

CHU Strasbourg - Hopital Hautepierre, Strasbourg

69120

RECRUITING

Universitaetsklinikum Heidelberg, Heidelberg

74104

RECRUITING

Ascension St. John Medical Center, Tulsa

75010

COMPLETED

Hôpital Lariboisière, Paris

75246

RECRUITING

Baylor Scott & White Health, Dallas

80113

ACTIVE_NOT_RECRUITING

Denver Metro Orthopedics, P.C., Englewood

82418

RECRUITING

BG Klinikum Murnau gGmbH, Murnau am Staffelsee

90502

RECRUITING

Harbor-UCLA Medical Center, Torrance

92350

COMPLETED

Hopital Marie Lannelongue, Le Plessis-Robinson

95817

RECRUITING

University of California Davis Health System, Sacramento

07103

RECRUITING

Rutgers, The State University of New Jersey, New Brunswick

15224-1722

RECRUITING

Allegheny Health Network, Pittsburgh

75390-8857

RECRUITING

University of Texas Southwestern Medical Center, Dallas

L8L 2X2

RECRUITING

Hamilton General Hospital, Hamilton

N6A 5A5

RECRUITING

London Health Sciences Centre (LHSC) - University Hospital, London

H3G 1A4

RECRUITING

Montreal General Hospital, Montreal

01307

RECRUITING

Universitaetsklinikum Carl Gustav Carus TU Dresden, Dresden

04103

RECRUITING

Universitaetsklinikum Leipzig AoeR, Leipzig

3810-501

RECRUITING

Centro Hospitalar do Baixo Vouga, E.P.E. - Unidade de Aveiro, Aveiro

3814-501

RECRUITING

Centro Hospitalar do Baixo Vouga, E.P.E. - Unidade de Aveiro, Aveiro

4434-502

RECRUITING

Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E, Vila Nova de Gaia

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Takeda Development Center Americas, Inc.

INDUSTRY

lead

Takeda

INDUSTRY