Head-to-Head safety check: which Clot-Reversal drug is safer before emergency surgery?
NCT ID NCT06429787
First seen Jul 16, 2026 · Last updated Sep 16, 2026 · Updated 5 times
Summary
This observational study compares the safety of two drugs, BALFAXAR and KCENTRA, used to reverse the effects of vitamin K antagonist blood thinners (like warfarin) in adults who need urgent surgery or an invasive procedure. The main goal is to see how often blood clots (thromboembolic events) occur within 45 days after treatment. The study will follow about 3,500 participants to determine if one drug has a better safety profile.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BALFAXAR (prothrombin complex concentrate, human-lans) and KCENTRA (prothrombin complex concentrate, human)
- What this could lead to
- If BALFAXAR proves safer than KCENTRA, it could become a preferred option for reversing blood thinners before emergency procedures, reducing complication risks.
- What could go wrong
- This is an observational study, not a randomized trial, so results may be influenced by patient differences. The study only looks at short-term safety, not long-term outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
About 3,574 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Jun 2032
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients at least 18 years of age who are currently on Vitamin K Antagonist treatments and received BALFAXAR or Kcentra for urgent reversal of VKA therapy within 48 hours prior to urgent surgery or invasive procedure. Octapharma will not actively enroll any of the 3,574 projected subjects into the study. Subjects meeting the minimum inclusion and exclusion criteria during the course of routine practice will be added to the study on a monthly basis until the sample size required for the analysis is achieved in each group.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subjects at least 18 years of age. 2. Subjects on VKA treatment. 3. Received 4F-PCC agent, BALFAXAR or Kcentra, for urgent reversal of within 48 hours prior to urgent surgery or invasive procedure. Exclusion Criteria: 1. History of TEE within 90 days before receipt of VKA reversal therapy. 2. Subjects treated with VKA reversal therapy and not undergoing urgent invasive procedure.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Octapharma Research Site
Boston, Massachusetts, 02215, United States