Health Trials

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

ConditionsVitamin K-Dependent Coagulation DefectSignificant Bleeding Risk
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOctapharma

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

History of TEE within 90 days before receipt of VKA reversal therapy.

Subjects treated with VKA reversal therapy and not undergoing urgent invasive procedure.

Trial design

Treatments tested in this trial

  • Balfaxar
  • Kcentra

Treatment groups

3,574 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Octapharma

Lead sponsor

Source ClinicalTrials.gov