Purpose of this Study
If people join this study, they will be watched closely while they are in the hospital for up to seven days after their surgery or procedure. They will also have a follow up visit about 28 days later. Some people may have additional follow up visits for up to two years if their doctor believes it is needed.
Participants will be placed into one of two groups by chance. One group will receive a study medicine called VMX C001. The other group will receive a medicine that is commonly used as part of usual medical care for people taking blood thinners who need urgent surgery. There is an equal chance of being placed in either group.
If a participant receives VMX C001, it will be given through a vein in a very short injection. Researchers want to learn if this treatment can help make urgent surgery or procedures safer for people who take blood thinning medicines.
Who Can Participate?
Eligibility
People can join this study if they are currently taking a type of blood thinner called a factor Xa inhibitor. They must need an urgent surgery or medical procedure that has a high risk of bleeding and requires the blood to clot normally. Participants must be expected to receive the usual medicines used for this situation. They cannot have taken other types of blood thinner medicines that are not factor Xa inhibitors. Researchers are studying whether a new medicine can safely help reverse the effects of blood thinners before urgent procedures.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is testing a new medicine called VMX C001 for people who take certain blood thinner medicines called factor Xa inhibitors. Sometimes people taking these blood thinners need emergency surgery or another urgent procedure that can cause serious bleeding.
Researchers want to learn if VMX C001 can quickly block the effects of the blood thinner so the blood can clot more normally when needed. The goal is to see if this treatment is safe and if it can help reduce bleeding risks during urgent surgeries and medical procedures.
Locations
Duke University Hospital
Visit Timing
Weekdays
Weekends
Evenings
Compensation
Yes
Spanish Materials Available
No
Study Details
Full 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)
Principal Investigator
Ara
Metjian
Protocol Number
PRO00120176
NCT ID
NCT07288489
Phase
III
Enrollment Status
Pending Open to Enrollment