Blood Loss, SurgicalPhase 3EQUILIBRIX-SNCT07288489
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.
A Phase 3 study testing Reltodecacog alfa and Usual Pharmacological Care in people with Blood Loss, Surgical and Coagulation Disorder, run by VarmX B.V. at 77 sites in 18 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Loss, Surgical, Coagulation Disorder
- What is being tested?
- Reltodecacog alfa and Usual Pharmacological Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 77 sitesin 18 countries
- Study dates
- 18 Aug 2026to Jan 2031
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
77 sites in 18 countries. Contact the study team or a site near you to ask about taking part.
77 sites in 18 countries
United States19 sites, 19 recruiting
- Not yet recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Chandler Regional Medical Center (CRMC)
Chandler, Arizona, 85224
- Recruiting
Ohio State McCampbell Outpatient Care
Columbus, Ohio, 43210
- Not yet recruiting
Duke University Medical Center
Durham, North Carolina, 27710
- Not yet recruiting
Texas Tech University Health Sciences Center - El Paso
El Paso, Texas, 79905
- Not yet recruiting
Denver Metro Orthopedics, P.C. - Englewood Location
Englewood, Colorado, 80113
- Not yet recruiting
Medical Center of the Rockies
Fort Collins, Colorado, 80523
- Recruiting
Memorial Hermann Hospital-TMC Investigational Drugs Services Pharmacy
Houston, Texas, 77030
- Not yet recruiting
The University of Texas McGovern Medical School at Houston
Houston, Texas, 77030
- Recruiting
University of Iowa Health Care
Iowa City, Iowa, 52242
- Recruiting
Intermountain Medical Center
Murray, Utah, 84107
- Not yet recruiting
Christiana Care
Newark, Delaware, 19718
- Recruiting
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73126
- Not yet recruiting
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
- Recruiting
HonorHealth John C Lincoln Medical Center
Phoenix, Arizona, 85020
- Not yet recruiting
Beaumont Hospital, Royal Oak
Royal Oak, Michigan, 48073
- Not yet recruiting
Stanford Hospital and Clinics
Stanford, California, 94305
- Recruiting
University of South Florida
Tampa, Florida, 33606
- Not yet recruiting
William Beaumont Hospital - Troy Campus
Troy, Michigan, 48085
Australia7 sites, 7 recruiting
- Not yet recruiting
St Vincent Hospital, Melbourne
Fitzroy, Victoria, 3065
- Recruiting
St Vincent Hospital, Melbourne
Fitzroy, Victoria, 3065
- Recruiting
Royal Brisbane and Women's Hospital (RBWH)
Herston, Queensland, 4006
- Recruiting
Alfred Health, Melbourne
Melbourne, Victoria, 3004
- Recruiting
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
- Recruiting
Mater Private Hospital
South Brisbane, Queensland, 4101
- Recruiting
Gold Coast University Hospital
Southport, Queensland, 4215
Bulgaria6 sites, 6 recruiting
- Recruiting
Multiprofile Hospital for Active Treatment AD Haskovo
Haskovo, 6304
- Recruiting
Multiprofile Hospital for Active Treatment Heart and Brain EAD
Pleven, Pleven, 5800
- Recruiting
UMBAL Kanev AD
Rousse, 7002
- Recruiting
UMHAT Sveta Ekaterina EAD
Sofia, 1431
- Recruiting
University Multiprofile Hospital for Active Treatment
Stara Zagora, 6003
- Recruiting
Multiprofile Hospital for Active Treatment Hristo Botev
Vratsa, 3000
Spain6 sites, 6 recruiting
- Recruiting
Hospital del Mar
Barcelona, 08003
- Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
- Recruiting
Hospital Universitario Ramon y Cajal
Madrid, 28034
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga, 29010
- Recruiting
Hospital Universitario Miguel Servet
Zaragoza, 50009
France5 sites, 5 recruiting
- Recruiting
Centre Hospitalier Universitaire d'Angers
Angers, 49933
- Recruiting
Centre Hospitalier Universitaire CHU
Dijon, 21000
- Recruiting
Centre Hospitalier Lyon-Sud
Pierre-Bénite, 69495
- Recruiting
CHU de Saint-Etienne - Hopital Bellevue
Saint Priest En Jarez, Pays de la Loire Region, 42270
- Recruiting
Hopitaux Universitaires de Strasbourg -Hopital de Hautepierre
Strasbourg, 67200
Italy5 sites, 5 recruiting
- Recruiting
Azienda Osperdaliera di Padova
Padova, 35128
- Recruiting
Fondazione Policlinico Universitario Agosti
Roma, 00168
- Recruiting
Policlinico Universitario Campus Bio-Medico
Rome, 00128
- Recruiting
IRCCS Humanitas Research Hospital
Rozzano, Milan, 20089
- Recruiting
Azienda Provinciale per i Servizi Sanitari - Presidio Ospedaliero S. Chiara
Trento, 38122
United Kingdom5 sites, 5 recruiting
- Recruiting
University Hospitals Birmingham NHS Foundation Trust - New Queen Elizabeth Hospital
Birmingham, B152TH
- Recruiting
NHS Lothian - Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
- Recruiting
Gloucestershire Hospitals NHS Foundation Trust - Gloucestershire Royal Hospital
Gloucester, Gloucestershire, GL1 3NN
- Recruiting
Guys and St Thomas NHS Foundation Trust - St Thomas Hospital
London, London, SE1 7EH
- Recruiting
Kings College Hospital NHS Foundation Trust
London, SE5 9RS
New Zealand4 sites, 4 recruiting
- Recruiting
Auckland City Hospital
Grafton, Auckand, 1023
- Recruiting
Waikato Hospital
Hamilton, Waikato Region, 3204
- Recruiting
Wellington Hospital
Newtown, Wellington Region, 6021
- Recruiting
Aotearoa Clinical Trials - Middlemore (ACTT) Middlemore Hospital
Papatoetoe, Auckland, 2025
Romania4 sites, 4 recruiting
- Recruiting
Institutul de Urgenta pentru Boli Cardiovasculare
Bucharest, 022328
- Recruiting
Spitalul Clinic de Urgenta Bagdasar-Arseni
Bucharest, 041915
- Recruiting
Spitalul Universitar de Urgenta Elias
Bucharest, 11461
- Recruiting
Spitalul Clinic Judetean de Urgenta Pius Brinzeu Timisoara
Timișoara, 300723
Hungary3 sites, 3 recruiting
- Recruiting
Semmelweis Egyetem Surgossegi Orvostar
Budapest, 1082
- Recruiting
Almasi Balogh Pal Korhaz
Ózd, 3600
- Recruiting
Tudomanyegyetem AOK Klinikai Kozpont Sebeszeti Klinika
Pécs, 7624
Japan3 sites, 3 recruiting
- Recruiting
Fukuoka Neurosurgical Hospital
Fukuoka-Shi, Fukuoka, 811-1313
- Recruiting
Shonan Kamakura General Hospital
Kamakura-Shi, Kanagawa, 247-8533
- Recruiting
Japanese Red Cross Kumamoto Hospital
Kumamoto-shi, Kumamoto, 861-8520
Belgium2 sites, 2 recruiting
- Recruiting
UZ Leuven
Leuven, 3000
- Recruiting
Clinique Saint-Pierre- Ottignies
Ottignies, Walloon Brabant, 1340
Germany2 sites, 2 recruiting
- Recruiting
Klinikum Dortmund gGmbH
Dortmund, 44137
- Recruiting
Universitatsklinikum Carl Gustav Carus Dresden
Dresden, Saxony, 01307
Serbia2 sites, 2 recruiting
- Recruiting
University Clinical Center Kragujevac
Kragujevac, 34000
- Recruiting
Klinicki Centar Vojvodine
Novi Sad, 21000
Austria1 site, 1 recruiting
- Recruiting
Ordensklinikum Linz Elisabethinen
Linz, 4020
Canada1 site, 1 recruiting
- Recruiting
St Michael's Hospital
Toronto, Ontario, M5B 1WB
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Centre - Cardiovascular Research Institute
Maastricht, 6229 HX
Portugal1 site, 1 recruiting
- Recruiting
Unidade Local de Saude Santo Antonio - Hospital de Santo Antonio
Porto
About this study
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)
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?
Read more
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.
- Conditions
- Blood Loss, Surgical, Coagulation Disorder
- Being tested
- Reltodecacog alfa, Usual Pharmacological Care
- Keywords
- Direct oral anticoagulant (DOAC), Human coagulation factor, Surgery, reltodecacog alfa
- Medical subject headings
- Blood Loss, Surgical, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reltodecacog alfaDrug
A fixed dose of reltodecacog alfa will be administered prior to commencement of procedure.
Usual Pharmacological CareDrug
Usual pharmacological care should be treatment planned to restore coagulation or support haemostasis for the required procedure.
| Study group | Role | What they receive |
|---|---|---|
| Reltodecacog alfa | Experimental | Participants will be administered a fixed dose of reltodecacog alfa before undergoing the required procedure. Receives: Drug: Reltodecacog alfa |
| Usual Pharmacological Care | Active comparator | Participants will be given the usual treatment used by the site for patients receiving FXa DOACs when undergoing the required procedure. Receives: Drug: Usual Pharmacological Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of VMX-C001 versus usual pharmacological care on haemostasis
Proportion of participants with good or excellent haemostatic efficacy during the required procedure.
Measured: From start to end of required procedure (Day 1).
Secondary outcomes (5)
Effect of VMX-C001 versus usual pharmacological care on FXa DOAC induced anticoagulation measured by dilute prothrombin time (dPT).
Change in dPT.
Measured: From Pre-procedure assessment compared to baseline (Randomisation) (Day 1).
Effect of VMX-C001 versus usual pharmacological care on FXa DOAC induced anticoagulation as measured by dilute Russell Viper Venom Time (dRVVT).
Change in dRVVT.
Measured: From Pre-procedure assessment compared to baseline (Randomisation) (Day 1).
Effect of VMX-C001 versus usual pharmacological care on the extent of actual blood loss compared to expected blood loss during procedure.
Percentage of expected blood loss.
Measured: From start to end of required procedure (Day 1).
Effect of VMX-C001 versus usual pharmacological care on bleeding severity.
Bleeding severity at the Start of procedure using a 5 point scale (grades 0 [no bleeding] to 4 [life threatening])
Measured: Start of procedure (Day 1).
Effect of VMX-C001 versus usual pharmacological care on bleeding severity prior to procedure.
Bleeding severity measured by blood loss.
Measured: Between Randomisation and Pre-procedure timepoint (Day 1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start18 Aug 2026
- Primary completionJan 2029 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Loss, SurgicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VarmX B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288489
- Sponsor's protocol ID
- VMX-C001-06
- Acronym
- EQUILIBRIX-S
- Status last verified
- Aug 2026
- First submitted
- 15 Dec 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: VarmX will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external, verified, qualified scientific and medical researchers. Information on the process and requirements for submitting a voluntary data sharing request for IPD can be obtained from info@varmx.com