Clinical Research Directory
Browse clinical research sites, groups, and studies.
Phase 3 Trial of Reltodecacog Alfa (VMX-C001) vs Usual Pharmacological Care in Patients Taking a FXa Direct Oral Anticoagulant Who Require Urgent Surgery With or Without Heparin.
Sponsor: VarmX B.V.
Summary
The goal of this clinical trial is to learn if reltodecacog alfa (VMX-C001) works to to allow blood clotting control in participants who take FXa Direct Oral Anticoagulants (DOACs) during surgery or other invasive procedures that carry a high risk of bleeding. The main question it aims to answer is: ● What is the proportion of participants in whom the stopping of bleeding was classed as good or excellent during the procedure, as judged by a group of experts who did not know which treatment was given? Researchers will compare a fixed dose of reltodecacog alfa (VMX-C001) to the usual treatment that would be given for the required procedure. Participants will: * Be given either a fixed dose of reltodecacog alfa (VMX-C001) or usual treatment before they undergo the required procedure in theatre * Have regular clinical assessments, including laboratory tests, during their hospital stay following the procedure * Return to the clinic for a check-up and tests approximately 28 days after the procedure was conducted.
Official title: A Phase 3 Prospective Randomised Clinical Trial of VMX-C001 vs Usual Pharmacological Care in Patients Receiving a FXa Direct Oral Anticoagulant (FXa DOAC) Who Require Urgent Surgery or Other Invasive Procedure That is Associated With a High Risk of Bleeding, With or Without Planned Administration of Heparin (EQUILIBRIX-S)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
800
Start Date
2026-08-18
Completion Date
2031-01
Last Updated
2026-10-14
Healthy Volunteers
No
Conditions
Interventions
Reltodecacog alfa
A fixed dose of reltodecacog alfa will be administered prior to commencement of procedure.
Usual Pharmacological Care
Usual pharmacological care should be treatment planned to restore coagulation or support haemostasis for the required procedure.
Locations (77)
Chandler Regional Medical Center (CRMC)
Chandler, Arizona, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
HonorHealth John C Lincoln Medical Center
Phoenix, Arizona, United States
Stanford Hospital and Clinics
Stanford, California, United States
Denver Metro Orthopedics, P.C. - Englewood Location
Englewood, Colorado, United States
Medical Center of the Rockies
Fort Collins, Colorado, United States
Christiana Care
Newark, Delaware, United States
University of South Florida
Tampa, Florida, United States
University of Iowa Health Care
Iowa City, Iowa, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beaumont Hospital, Royal Oak
Royal Oak, Michigan, United States
William Beaumont Hospital - Troy Campus
Troy, Michigan, United States
Duke University Medical Center
Durham, North Carolina, United States
Ohio State McCampbell Outpatient Care
Columbus, Ohio, United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Texas Tech University Health Sciences Center - El Paso
El Paso, Texas, United States
Memorial Hermann Hospital-TMC Investigational Drugs Services Pharmacy
Houston, Texas, United States
The University of Texas McGovern Medical School at Houston
Houston, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Royal Brisbane and Women's Hospital (RBWH)
Herston, Queensland, Australia
Mater Private Hospital
South Brisbane, Queensland, Australia
Gold Coast University Hospital
Southport, Queensland, Australia
St Vincent Hospital, Melbourne
Fitzroy, Victoria, Australia
St Vincent Hospital, Melbourne
Fitzroy, Victoria, Australia
Alfred Health, Melbourne
Melbourne, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Ordensklinikum Linz Elisabethinen
Linz, Austria
Clinique Saint-Pierre- Ottignies
Ottignies, Walloon Brabant, Belgium
UZ Leuven
Leuven, Belgium
Multiprofile Hospital for Active Treatment Heart and Brain EAD
Pleven, Pleven, Bulgaria
Multiprofile Hospital for Active Treatment AD Haskovo
Haskovo, Bulgaria
UMBAL Kanev AD
Rousse, Bulgaria
UMHAT Sveta Ekaterina EAD
Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment
Stara Zagora, Bulgaria
Multiprofile Hospital for Active Treatment Hristo Botev
Vratsa, Bulgaria
St Michael's Hospital
Toronto, Ontario, Canada
CHU de Saint-Etienne - Hopital Bellevue
Saint Priest En Jarez, Pays de la Loire Region, France
Centre Hospitalier Universitaire d'Angers
Angers, France
Centre Hospitalier Universitaire CHU
Dijon, France
Centre Hospitalier Lyon-Sud
Pierre-Bénite, France
Hopitaux Universitaires de Strasbourg -Hopital de Hautepierre
Strasbourg, France
Universitatsklinikum Carl Gustav Carus Dresden
Dresden, Saxony, Germany
Klinikum Dortmund gGmbH
Dortmund, Germany
Semmelweis Egyetem Surgossegi Orvostar
Budapest, Hungary
Almasi Balogh Pal Korhaz
Ózd, Hungary
Tudomanyegyetem AOK Klinikai Kozpont Sebeszeti Klinika
Pécs, Hungary
IRCCS Humanitas Research Hospital
Rozzano, Milan, Italy
Azienda Osperdaliera di Padova
Padova, Italy
Fondazione Policlinico Universitario Agosti
Roma, Italy
Policlinico Universitario Campus Bio-Medico
Rome, Italy
Azienda Provinciale per i Servizi Sanitari - Presidio Ospedaliero S. Chiara
Trento, Italy
Shonan Kamakura General Hospital
Kamakura-Shi, Kanagawa, Japan
Fukuoka Neurosurgical Hospital
Fukuoka-Shi, Fukuoka, Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto-shi, Kumamoto, Japan
Maastricht University Medical Centre - Cardiovascular Research Institute
Maastricht, Netherlands
Auckland City Hospital
Grafton, Auckand, New Zealand
Aotearoa Clinical Trials - Middlemore (ACTT) Middlemore Hospital
Papatoetoe, Auckland, New Zealand
Waikato Hospital
Hamilton, Waikato Region, New Zealand
Wellington Hospital
Newtown, Wellington Region, New Zealand
Unidade Local de Saude Santo Antonio - Hospital de Santo Antonio
Porto, Portugal
Institutul de Urgenta pentru Boli Cardiovasculare
Bucharest, Romania
Spitalul Clinic de Urgenta Bagdasar-Arseni
Bucharest, Romania
Spitalul Universitar de Urgenta Elias
Bucharest, Romania
Spitalul Clinic Judetean de Urgenta Pius Brinzeu Timisoara
Timișoara, Romania
University Clinical Center Kragujevac
Kragujevac, Serbia
Klinicki Centar Vojvodine
Novi Sad, Serbia
Hospital del Mar
Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain
Gloucestershire Hospitals NHS Foundation Trust - Gloucestershire Royal Hospital
Gloucester, Gloucestershire, United Kingdom
Guys and St Thomas NHS Foundation Trust - St Thomas Hospital
London, London, United Kingdom
University Hospitals Birmingham NHS Foundation Trust - New Queen Elizabeth Hospital
Birmingham, United Kingdom
NHS Lothian - Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
Kings College Hospital NHS Foundation Trust
London, United Kingdom