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

Launched by OCTAPHARMA · May 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety of two medications, BALFAXAR and KCENTRA, which are used to reverse the effects of certain blood-thinning medications (called vitamin K antagonists) in adults who need urgent surgery or invasive procedures. These blood thinners can increase the risk of significant bleeding, so it's important to quickly restore normal blood clotting before surgery. The trial is currently recruiting participants aged 18 and older who have been on these blood thinners and have received either BALFAXAR or KCENTRA to reverse their medication within 48 hours before their surgery.

To be eligible for this study, participants must be at least 18 years old and currently taking a vitamin K antagonist. They should have received either BALFAXAR or KCENTRA specifically to prepare for an urgent procedure. However, individuals who have had certain heart procedures recently or who are not undergoing surgery will not be included. Participants will be monitored for safety during the trial, helping researchers understand how well these medications work in a real-world setting.

Gender

ALL

Eligibility criteria

• 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.