RecruitingPhase 3NCT05156983

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

A Phase 3, Prospective, Randomized, Open-label, Adaptive Group Sequential, Multicenter Trial With Blinded Endpoint Assessment to Evaluate the Efficacy and Safety of TAK-330 for the Reversal of Direct Oral Factor Xa Inhibitor-induced Anticoagulation in Patients Requiring Urgent Surgery/Invasive Procedure

Sponsor

Takeda

Enrollment

328 participants

Start Date

Aug 24, 2022

Study Type

INTERVENTIONAL

Conditions

Coagulation Disorder

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing TAK-330, a new drug designed to quickly reverse the blood-thinning effects of Factor Xa inhibitors (such as rivaroxaban, apixaban, and edoxaban) in patients who need urgent surgery. These blood thinners prevent dangerous clots but can cause life-threatening bleeding during surgery. TAK-330 is being evaluated as a fast-acting reversal agent to allow surgery to proceed safely. You may be eligible if: - You are 18 years or older - You are currently taking a Factor Xa inhibitor (rivaroxaban, apixaban, or edoxaban) - You need urgent surgery that carries high bleeding risk - Your surgery must occur within 15 hours of your last dose (or you have lab evidence of elevated drug levels if beyond 15 hours) - You or your legal representative is willing to consent You may NOT be eligible if: - Your expected survival is less than 30 days even with treatment - You have had a heart attack, stroke, blood clot, or been hospitalized for unstable angina within the past 90 days - You have active major bleeding (requiring surgery or significant transfusion) other than permitted subdural hemorrhages - You have a known blood clotting disorder or hereditary bleeding disorder - Your platelet count is below 50,000 - You have acute or chronic liver failure (Child-Pugh C) - You are on dialysis for kidney failure - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

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

DRUGTAK-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.

DRUGSOC 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.

Locations(64)

University of Arkansas Medical Sciences

Arkansas City, Arkansas, United States

University of California Davis Health System

Sacramento, California, United States

Denver Metro Orthopedics, P.C.

Englewood, Colorado, United States

University of Florida

Gainesville, Florida, United States

Rutgers, The State University of New Jersey

New Brunswick, New Jersey, United States

ECU Health Medical Center

Greenville, North Carolina, United States

Metro Health Medical Center

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Ascension St. John Medical Center

Tulsa, Oklahoma, United States

University of Pennsylvania - Perelman School of Medicine

Philadelphia, Pennsylvania, United States

UPMC

Pittsburgh, Pennsylvania, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Carilion Medical Center

Virginia Beach, Virginia, United States

Hospital Universitario Austral

Buenos Aires, Argentina

Clinica Zabala

Ciudad Autonoma Buenos Aires, Argentina

Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia - FLENI

Ciudad Autonoma Buenos Aires, Argentina

Hospital Privado de Rosario

Santa Fe, Argentina

LKH - Universitaetsklinikum Graz

Graz, Austria

Landesklinikum Neunkirchen

Neunkirchen, Austria

ZOL

Genk, Limburg, Belgium

Jessa Ziekenhuis Hospital

Hasselt, Limburg, Belgium

AZ Groeninge

Kortrijk, Belgium

CHU UCL Namur

Therasse 1, Belgium

Irmandade da Santa Casa da Misericordia de Santos

Santos, São Paulo, Brazil

Hospital de Clinicas de Ijui

Ijuí, Brazil

Hospital Sao Paulo

São Paulo, Brazil

Hamilton General Hospital

Hamilton, Ontario, Canada

London Health Sciences Centre (LHSC) - University Hospital

London, Ontario, Canada

Unity Health Toronto St Michaels Hospital

Toronto, Ontario, Canada

Montreal General Hospital

Montreal, Quebec, Canada

The Ottawa Hospital - General Campus

Ontario, Canada

CHU de Quebec- Hopital de l Enfant Jesus

Québec, Canada

Fakultni nemocnice Brno

Jihlavska, Czechia

Fakultni nemocnice v Motole

Prague (Praha), Czechia

Dept of II. interni klinika - gastroenterologie

Srobarova C, Czechia

CHU Strasbourg - Hopital Hautepierre

Strasbourg, Bas Rhin, France

Hospital michallon - CHUGA

Grenoble, France

Hopital Marie Lannelongue

Le Plessis-Robinson, France

Hôpital Lariboisière

Paris, France

GH Paris Saint Joseph

Paris, France

BG Klinikum Murnau gGmbH

Murnau am Staffelsee, Bavaria, Germany

Universitaetsklinikum Carl Gustav Carus TU Dresden

Dresden, Saxony, Germany

Universitaetsklinikum Leipzig AoeR

Leipzig, Saxony, Germany

Klinikum Dortmund gGmbH

Murnau am Staffelsee, Germany

Konstantopoulio General Hospital, N.Ionia

Nea Ionia, Attica, Greece

Bekes Varmegyei Kozponti Korhaz

Békéscsaba, Attica, Hungary

Ozdi Almasi Balogh Pal Korhaz

Szeged, Attica, Hungary

Semmelweis Egyetem

Budapest, Hungary

Debreceni Egyetem

Debrecen, Hungary

Shamir Medical Center (Assaf Harofe)

Beer Yaacov, Israel

Soroka Medical Center

Beersheba, Israel

Rambam Health Care Campus

Haifa, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Hadassah University Hospital - Ein Kerem

Jerusalem, Israel

Rabin MC

Petah Tikva, Israel

Chaim Sheba Medical Center

Ramat Gan, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Uniwersytecki Szpital Kliniczny nr 1 im. prof. Tadeusza Sokołowskiego PUM w Szczecinie

Szczecin, Poland

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

Aveiro, Portugal

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

Aveiro, Portugal

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

Rua Conceição Fernandes, Portugal

Hospital Clinico Universitario de Salamanca

Salamnca, Salamanca, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

View Full Details on ClinicalTrials.gov

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

Visit

NCT05156983

Related Trials

SWIFT - SWIss Factor XIII Trial in PPH

NCT064819959 locations

Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)

NCT0427840451 locations