Head-to-Head safety check: which Clot-Reversal drug is safer before emergency surgery?
NCT ID NCT06429787
First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time
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.
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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
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Study contacts
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Contact
Phone: •••-•••-•••• Email: •••••@•••••
Locations
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Octapharma Research Site
RECRUITINGBoston, Massachusetts, 02215, United States