RecruitingPhase 3NCT04867837

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

Study of Four-factor Prothrombin Complex Concentrate, OCTAPLEX, in Patients With Acute Major Bleeding on Direct Oral Anticoagulant (DOAC) Therapy With Factor Xa Inhibitor

Sponsor

Octapharma

Enrollment

260 participants

Start Date

Sep 1, 2021

Study Type

INTERVENTIONAL

Conditions

Acute Major Bleeding

Summary

This is a multicentre, prospective, randomised, double-blinded, group-sequential, parallel-group, adaptive design, phase 3 study to demonstrate the haemostatic efficacy and safety of four-factor prothrombin complex concentrate, OCTAPLEX, in patients with acute major bleeding on DOAC therapy with factor Xa inhibitor. Patients will be randomised 1:1 to either of two study groups: low-dose vs. high-dose OCTAPLEX.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Octaplex for people with acute major bleeding. The study is currently recruiting participants at 63 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGOctaplex

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

Locations(63)

Harbor-UCLA Medical Center

Torrance, California, United States

The University of Florida

Gainesville, Florida, United States

St. Mary's Medical Center

West Palm Beach, Florida, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

OU Health - University of Oklahoma Medical Center

Oklahoma City, Oklahoma, United States

Oregon Health & Science University

Portland, Oregon, United States

Ascension Seton Medical Center Austin

Austin, Texas, United States

Dell Seton Medical Center at the University of Texas

Austin, Texas, United States

Klinikum Klagenfurt am Wörthersee Anästhesiologie und Intensivmedizin

Klagenfurt, Austria

University Clinical Centre of the Republic of Srpska

Banja Luka, Bosnia and Herzegovina

Univeristy Clinical Hospital Mostar

Mostar, Bosnia and Herzegovina

Clinical Center University of Sarajevo

Sarajevo, Bosnia and Herzegovina

University Clinical Center Tuzla

Tuzla, Bosnia and Herzegovina

Clinical Hospital Dubrava

Zagreb, Croatia

University Hospital Centre Zagreb

Zagreb, Croatia

Centre Hospitalier Universitaire Francois Mitterand

Dijon, France

Pineo Medical Ecosystem

Tbilisi, Georgia

Tbilisi Institute of Medicine

Tbilisi, Georgia

LTS ,, Israel-Geoargian Medical Research clinic Helsicore"

Tbilisi, Georgia

New Hospitals

Tbilisi, Georgia

K.Eristavi National Center of Experimental and Clinical Surgery

Tbilisi, Georgia

Universitaetsklinikum Aachen, Klinik fuer Anaesthesiologie

Aachen, Germany

Universitatsklinikum Erlangen

Erlangen, Germany

Universitaetsklinikum Essen, Klinik für Anästhesiologie und Intensivmedizin-Hufelandstraße

Essen, Germany

Universitaetsklinikum Frankfurt - Klinik fuer Anaesthesiologie, Intensivmedizin und Schmerztherapie

Frankfurt am Main, Germany

Heidelberg University Hospital Neurologische Universitätsklinik

Heidelberg, Germany

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

Tübingen, Germany

Ospedale Maggiore - IRCCS Istituto di Scienze Neurologiche di Bologna

Bologna, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

San Raffaele Hospital

Milan, Italy

Azienda Ospedaliero -Universitaria di Modena

Modena, Italy

Ospedale Santa Maria della Misericordia

Perugia, Italy

Azienda Ospedaliero-Universitaria Senese

Siena, Italy

Ośrodek Badań Klinicznych BD Research

Iława, Poland

Clinical Research Center at Special Hospital Stefan Zeromski

Krakow, Poland

Military Institute of Medicine

Warsaw, Poland

Samodzielny Publiczny Zakład Opieki Zdrowotnej w Łęcznej

Łęczna, Poland

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Dr. Peset

Valencia, Spain

Hospital Universitario y Politecnico La Fe

Valencia, Spain

SBU Adana City Education and Research Hospital

Adana, Turkey (Türkiye)

Ankara University Faculty of Medicine

Ankara, Turkey (Türkiye)

İnönü University Faculty of Medicine

Battalgazi, Turkey (Türkiye)

Health Sciences University Bursa High Specialization Training and Research Hospital

Bursa, Turkey (Türkiye)

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

Istanbul, Turkey (Türkiye)

Ege University Faculty of Medicine

Izmir, Turkey (Türkiye)

Kahramanmaraş Sütçü İmam University Faculty of Medicine

Kahramanmaraş, Turkey (Türkiye)

Mersin University Faculty of Medicine

Mersin, Turkey (Türkiye)

Ondokuz Mayıs University Faculty of Medicine

Samsun, Turkey (Türkiye)

Karadeniz Technical University

Trabzon, Turkey (Türkiye)

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

Dnipro, Ukraine

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

Ivano-Frankivsk, Ukraine

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

Ivano-Frankivsk, Ukraine

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

Kropyvnytskyi, Ukraine

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

Kyiv, Ukraine

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

Lviv, Ukraine

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

Basingstoke, Hampshire, United Kingdom

Nottingham University Hospital

Nottingham, United Kingdom

Southampton General Hospital

Southampton, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04867837