What this study is
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.
What's being tested
- Reltodecacog alfa
Intervention · DRUG
A fixed dose of reltodecacog alfa will be administered prior to commencement of procedure.
- Usual Pharmacological Care
Intervention · DRUG
Usual pharmacological care should be treatment planned to restore coagulation or support haemostasis for the required procedure.
Study details
- 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)
- Sponsor
- VarmX B.V.
- Conditions
- Blood Loss, Surgical · Coagulation Disorder
- Enrolling
- 800 people
- Starts
- 2026-08-18
- Est. completion
- 2031-01
- Design
- Open-label, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Male or female patient aged ≥18 years.
- The patient or legally authorised representative (LAR) has given written informed consent.
- The patient requires urgent surgery/procedure for which the risk of bleeding is considered high and for which haemostasis is considered necessary.
- The patient has a significant FXa DOAC level at the time of procedure.
- The patient would require treatment (usual pharmacological care) to restore coagulation for the required procedure.
- The patient must be willing to use appropriate contraception.
You can't join if
- The patient is known for any reason, other than administration of a FXa DOAC, to have an increased risk of bleeding compared to a patient in a similar clinical situation.
- The patient has received any non FXa DOAC anticoagulants within 7 days of Screening or has received heparin (UFH or LMWH) within 3 days of Screening.
- The patient has received any of the prespecified medications not allowed in the 7 days prior to Randomisation.
- The patient was treated with an investigational drug <30 days or 5 half-lives, whichever is longer, prior to Screening.
- Expected survival, in the Investigator's judgement, is <3 months due to comorbidity.
- Patients in whom the Investigator considers it is not possible to estimate the expected blood loss.
- Known "Do Not Resuscitate" order or similar advanced directive.
- Cardiogenic shock at the time of screening unless related to the need for the required procedure.
- The patient has sepsis (including severe sepsis or septic shock) at the time of screening.
- The patient is pregnant or a lactating female.
- Known hypersensitivity to any component of VMX-C001 or hamster proteins.
- Patients who, in the opinion of the Investigator, should not participate in the study for any other reason, or inability to comply with the protocol.
- Prior exposure to VMX-C001.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (77)
77 openChandler Regional Medical Center (CRMC)
Chandler, Arizona, United States
RecruitingSt. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Not yet recruitingHonorHealth John C Lincoln Medical Center
Phoenix, Arizona, United States
RecruitingStanford Hospital and Clinics
Stanford, California, United States
Not yet recruitingDenver Metro Orthopedics, P.C. - Englewood Location
Englewood, Colorado, United States
Not yet recruitingMedical Center of the Rockies
Fort Collins, Colorado, United States
Not yet recruitingChristiana Care
Newark, Delaware, United States
Not yet recruitingUniversity of South Florida
Tampa, Florida, United States
RecruitingUniversity of Iowa Health Care
Iowa City, Iowa, United States
RecruitingMassachusetts General Hospital
Boston, Massachusetts, United States
Not yet recruitingBeaumont Hospital, Royal Oak
Royal Oak, Michigan, United States
Not yet recruitingWilliam Beaumont Hospital - Troy Campus
Troy, Michigan, United States
Not yet recruitingDuke University Medical Center
Durham, North Carolina, United States
Not yet recruitingOhio State McCampbell Outpatient Care
Columbus, Ohio, United States
RecruitingThe University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
RecruitingTexas Tech University Health Sciences Center - El Paso
El Paso, Texas, United States
Not yet recruitingMemorial Hermann Hospital-TMC Investigational Drugs Services Pharmacy
Houston, Texas, United States
RecruitingThe University of Texas McGovern Medical School at Houston
Houston, Texas, United States
Not yet recruitingIntermountain Medical Center
Murray, Utah, United States
Recruiting
58 sites outside the US
Royal Brisbane and Women's Hospital (RBWH)
Herston, Queensland, Australia
RecruitingMater Private Hospital
South Brisbane, Queensland, Australia
RecruitingGold Coast University Hospital
Southport, Queensland, Australia
RecruitingSt Vincent Hospital, Melbourne
Fitzroy, Victoria, Australia
Not yet recruitingSt Vincent Hospital, Melbourne
Fitzroy, Victoria, Australia
RecruitingAlfred Health, Melbourne
Melbourne, Victoria, Australia
RecruitingFiona Stanley Hospital
Murdoch, Western Australia, Australia
RecruitingOrdensklinikum Linz Elisabethinen
Linz, Austria
RecruitingClinique Saint-Pierre- Ottignies
Ottignies, Walloon Brabant, Belgium
RecruitingUZ Leuven
Leuven, Belgium
RecruitingMultiprofile Hospital for Active Treatment Heart and Brain EAD
Pleven, Pleven, Bulgaria
RecruitingMultiprofile Hospital for Active Treatment AD Haskovo
Haskovo, Bulgaria
RecruitingUMBAL Kanev AD
Rousse, Bulgaria
RecruitingUMHAT Sveta Ekaterina EAD
Sofia, Bulgaria
RecruitingUniversity Multiprofile Hospital for Active Treatment
Stara Zagora, Bulgaria
RecruitingMultiprofile Hospital for Active Treatment Hristo Botev
Vratsa, Bulgaria
RecruitingSt Michael's Hospital
Toronto, Ontario, Canada
RecruitingCHU de Saint-Etienne - Hopital Bellevue
Saint Priest En Jarez, Pays de la Loire Region, France
RecruitingCentre Hospitalier Universitaire d'Angers
Angers, France
RecruitingCentre Hospitalier Universitaire CHU
Dijon, France
RecruitingCentre Hospitalier Lyon-Sud
Pierre-Bénite, France
RecruitingHopitaux Universitaires de Strasbourg -Hopital de Hautepierre
Strasbourg, France
RecruitingUniversitatsklinikum Carl Gustav Carus Dresden
Dresden, Saxony, Germany
RecruitingKlinikum Dortmund gGmbH
Dortmund, Germany
RecruitingSemmelweis Egyetem Surgossegi Orvostar
Budapest, Hungary
RecruitingAlmasi Balogh Pal Korhaz
Ózd, Hungary
RecruitingTudomanyegyetem AOK Klinikai Kozpont Sebeszeti Klinika
Pécs, Hungary
RecruitingIRCCS Humanitas Research Hospital
Rozzano, Milan, Italy
RecruitingAzienda Osperdaliera di Padova
Padova, Italy
RecruitingFondazione Policlinico Universitario Agosti
Roma, Italy
RecruitingPoliclinico Universitario Campus Bio-Medico
Rome, Italy
RecruitingAzienda Provinciale per i Servizi Sanitari - Presidio Ospedaliero S. Chiara
Trento, Italy
RecruitingShonan Kamakura General Hospital
Kamakura-Shi, Kanagawa, Japan
RecruitingFukuoka Neurosurgical Hospital
Fukuoka-Shi, Fukuoka, Japan
RecruitingJapanese Red Cross Kumamoto Hospital
Kumamoto-shi, Kumamoto, Japan
RecruitingMaastricht University Medical Centre - Cardiovascular Research Institute
Maastricht, Netherlands
RecruitingAuckland City Hospital
Grafton, Auckand, New Zealand
RecruitingAotearoa Clinical Trials - Middlemore (ACTT) Middlemore Hospital
Papatoetoe, Auckland, New Zealand
RecruitingWaikato Hospital
Hamilton, Waikato Region, New Zealand
RecruitingWellington Hospital
Newtown, Wellington Region, New Zealand
RecruitingUnidade Local de Saude Santo Antonio - Hospital de Santo Antonio
Porto, Portugal
RecruitingInstitutul de Urgenta pentru Boli Cardiovasculare
Bucharest, Romania
RecruitingSpitalul Clinic de Urgenta Bagdasar-Arseni
Bucharest, Romania
RecruitingSpitalul Universitar de Urgenta Elias
Bucharest, Romania
RecruitingSpitalul Clinic Judetean de Urgenta Pius Brinzeu Timisoara
Timișoara, Romania
RecruitingUniversity Clinical Center Kragujevac
Kragujevac, Serbia
RecruitingKlinicki Centar Vojvodine
Novi Sad, Serbia
RecruitingHospital del Mar
Barcelona, Spain
RecruitingHospital Clinic de Barcelona
Barcelona, Spain
RecruitingHospital Universitario Ramon y Cajal
Madrid, Spain
RecruitingHospital Universitario La Paz
Madrid, Spain
RecruitingHospital Universitario Virgen de la Victoria
Málaga, Spain
RecruitingHospital Universitario Miguel Servet
Zaragoza, Spain
RecruitingGloucestershire Hospitals NHS Foundation Trust - Gloucestershire Royal Hospital
Gloucester, Gloucestershire, United Kingdom
RecruitingGuys and St Thomas NHS Foundation Trust - St Thomas Hospital
London, London, United Kingdom
RecruitingUniversity Hospitals Birmingham NHS Foundation Trust - New Queen Elizabeth Hospital
Birmingham, United Kingdom
RecruitingNHS Lothian - Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
RecruitingKings College Hospital NHS Foundation Trust
London, United Kingdom
Recruiting
Study team
Sponsor
VarmX B.V.
Study ID VMX-C001-06
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.