RecruitingNot Applicable

Post Marketing Observational Study on Safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure

United States3,574 participantsStarted 2025-02-14

Plain-language summary

Post marketing observational study on safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Subjects at least 18 years of age.
✓. Subjects on VKA treatment.
✓. Received 4F-PCC agent, BALFAXAR or Kcentra, for urgent reversal of within 48 hours prior to urgent surgery or invasive procedure.

Exclusion criteria

✕. History of TEE within 90 days before receipt of VKA reversal therapy.
✕. Subjects treated with VKA reversal therapy and not undergoing urgent invasive procedure.

What they're measuring

TEEs within 45 days following VKA reversal treatment

Timeframe: 45 days

Trial details

NCT IDNCT06429787

SponsorOctapharma

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2031-12-31

Contact for this trial

Patrick Murphy

8663371868 p.murphy@crmg-usa.com

View on ClinicalTrials.gov More Vitamin K-Dependent Coagulation Defect trials