Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor

PHASE3RecruitingINTERVENTIONAL
Enrollment

260

Participants

Timeline

Start Date

September 1, 2021

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Acute Major Bleeding
Interventions
DRUG

Octaplex

Four-factor prothrombin complex concentrate (4F-PCC)

Trial Locations (63)

112

RECRUITING

"LTS ,, Israel-Geoargian Medical Research clinic Helsicore", Tbilisi

114

RECRUITING

New Hospitals, Tbilisi

159

RECRUITING

K.Eristavi National Center of Experimental and Clinical Surgery, Tbilisi

6230

RECRUITING

Ankara University Faculty of Medicine, Ankara

9020

TERMINATED

Klinikum Klagenfurt am Wörthersee Anästhesiologie und Intensivmedizin, Klagenfurt

10000

TERMINATED

Clinical Hospital Dubrava, Zagreb

TERMINATED

University Hospital Centre Zagreb, Zagreb

16300

RECRUITING

Health Sciences University Bursa High Specialization Training and Research Hospital, Bursa

20122

TERMINATED

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

20132

TERMINATED

San Raffaele Hospital, Milan

21000

TERMINATED

Centre Hospitalier Universitaire Francois Mitterand, Dijon

26006

RECRUITING

"Medical and Diagnostic Center of Private Enterprise of Private Manufacturing Company Acinus", Kropyvnytskyi

28034

RECRUITING

Hospital Universitario Ramón y Cajal, Madrid

28041

RECRUITING

Hospital Universitario 12 de Octubre, Madrid

32610

RECRUITING

The University of Florida, Gainesville

33343

RECRUITING

Mersin University Faculty of Medicine, Mersin

33407

RECRUITING

St. Mary's Medical Center, West Palm Beach

34093

RECRUITING

Istanbul University Istanbul Faculty of Medicine Department of Internal Diseases, Division of Hematology, Istanbul

35100

RECRUITING

Ege University Faculty of Medicine, Izmir

39216

TERMINATED

University of Mississippi Medical Center, Jackson

40133

RECRUITING

Ospedale Maggiore - IRCCS Istituto di Scienze Neurologiche di Bologna, Bologna

41125

ACTIVE_NOT_RECRUITING

Azienda Ospedaliero -Universitaria di Modena, Modena

44280

RECRUITING

İnönü University Faculty of Medicine, Battalgazi

46017

ACTIVE_NOT_RECRUITING

Hospital Dr. Peset, Valencia

46026

RECRUITING

Hospital Universitario y Politecnico La Fe, Valencia

46040

RECRUITING

Kahramanmaraş Sütçü İmam University Faculty of Medicine, Kahramanmaraş

49006

RECRUITING

Public Non-profit Enterprise Clinical Emergency Care Hospital of Dnipro City Counsil, Dnipro

52074

ACTIVE_NOT_RECRUITING

Universitaetsklinikum Aachen, Klinik fuer Anaesthesiologie, Aachen

53100

ACTIVE_NOT_RECRUITING

Azienda Ospedaliero-Universitaria Senese, Siena

55280

RECRUITING

Ondokuz Mayıs University Faculty of Medicine, Samsun

55415

TERMINATED

Hennepin County Medical Center, Minneapolis

60590

RECRUITING

Universitaetsklinikum Frankfurt - Klinik fuer Anaesthesiologie, Intensivmedizin und Schmerztherapie, Frankfurt am Main

61080

RECRUITING

Karadeniz Technical University, Trabzon

69120

RECRUITING

Heidelberg University Hospital Neurologische Universitätsklinik, Heidelberg

71000

ACTIVE_NOT_RECRUITING

Clinical Center University of Sarajevo, Sarajevo

73104

TERMINATED

OU Health - University of Oklahoma Medical Center, Oklahoma City

75000

ACTIVE_NOT_RECRUITING

University Clinical Center Tuzla, Tuzla

76008

ACTIVE_NOT_RECRUITING

Public Non-profit Enterprise Regional Clinical Hospital of lvano-Frankivsk Regional Council, Ivano-Frankivsk

76025

ACTIVE_NOT_RECRUITING

Public Non-profit Enterprise Central City Clinical Hospital of Ivano-Frankivsk City Council, Ivano-Frankivsk

78000

TERMINATED

University Clinical Centre of the Republic of Srpska, Banja Luka

78712

TERMINATED

Ascension Seton Medical Center Austin, Austin

TERMINATED

Dell Seton Medical Center at the University of Texas, Austin

79010

RECRUITING

Public Non-profit Enterprise of Lviv Regional Council Lviv Public non profit Regional Clinical Hospital, Lviv

88000

TERMINATED

Univeristy Clinical Hospital Mostar, Mostar

90509

TERMINATED

Harbor-UCLA Medical Center, Torrance

91054

RECRUITING

Universitatsklinikum Erlangen, Erlangen

97239

TERMINATED

Oregon Health & Science University, Portland

02215

TERMINATED

Beth Israel Deaconess Medical Center, Boston

00108

RECRUITING

Pineo Medical Ecosystem, Tbilisi

00160

RECRUITING

Tbilisi Institute of Medicine, Tbilisi

D-45147

RECRUITING

Universitaetsklinikum Essen, Klinik für Anästhesiologie und Intensivmedizin-Hufelandstraße, Essen

Germany

RECRUITING

Universitatsklinikum Tubingen Hertie-lnstitut fur klinische Hirnforschung (HIH) / Neurologische Universitatsklinik, Tübingen

06156

RECRUITING

Ospedale Santa Maria della Misericordia, Perugia

14-200

RECRUITING

Ośrodek Badań Klinicznych BD Research, Iława

31-913

RECRUITING

Clinical Research Center at Special Hospital Stefan Zeromski, Krakow

04-141

TERMINATED

Military Institute of Medicine, Warsaw

21-010

RECRUITING

Samodzielny Publiczny Zakład Opieki Zdrowotnej w Łęcznej, Łęczna

00261

RECRUITING

Hospital Universitario La Paz, Madrid

01370

RECRUITING

SBU Adana City Education and Research Hospital, Adana

01133

NOT_YET_RECRUITING

Public Non-profit Enterprise Kyiv City Clinical Hospital #17 of Kyiv City Council Executive Body, Kyiv

RG24 9NA

TERMINATED

North Hampshire Hospitals NHS Foundation Trust, Basingstoke and North Hampshire Hospital, Basingstoke

NG51PB

TERMINATED

Nottingham University Hospital, Nottingham

SO16 SYD

TERMINATED

Southampton General Hospital, Southampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Octapharma

INDUSTRY

NCT04867837 - Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor | Biotech Hunter | Biotech Hunter