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

NCT06429787 | Recruiting FDA Drug

• 1 other identifier: LEX-212
• Study Type: observational
• Target: 3,574
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Vitamin K-Dependent Coagulation Defect; Significant Bleeding Risk

Outcome Measures

Primary Outcomes (1)

• TEEs within 45 days following VKA reversal treatment

  Proportion of subjects diagnosed with TEEs within 45 days following VKA reversal treatment with BALFAXAR compared to proportion of subjects diagnosed with TEEs within the same period following VKA reversal treatment with Kcentra.

  45 days

Secondary Outcomes (5)

• TEEs within 7 and 14 days following VKA reversal treatment

  14 days

• Median Time to TEEs

  45 days

• All Cause Mortality

  45 days

• Median Time to All Cause Mortality

  45 days

• Rate of Fatal TEEs

  45 days

Study Arms (2)

BALFAXAR® (500 IU)

BALFAXAR will be administered by intravenous (IV) infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min). Dosing is individualized based on the patient's baseline International Normalized Ratio (INR) value and body weight

Drug: Balfaxar

Kcentra® (500 IU)

KCENTRA will be administered by intravenous infusion at of 0.12 mL/kg/min (\~3 units/kg/min) up to a maximum rate of 8.4 mL/min (\~210 units/min). Dosing is individualized based on the patient's baseline International Normalized Ratio (INR) value and body weight.

Drug: Kcentra

Interventions

Balfaxar DRUG

BALFAXAR (prothrombin complex concentrate, human-lans) is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for an urgent surgery/invasive procedure

BALFAXAR® (500 IU)

Kcentra DRUG

KCENTRA, Prothrombin Complex Concentrate (Human), is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with: * acute major bleeding or * need for an urgent surgery/invasive procedure

Kcentra® (500 IU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Octapharma: lead

Study Sites (1)

Octapharma Research Site

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Vitamin K-Dependent Clotting Factors, Combined Deficiency Of, 1

Central Study Contacts

Patrick Murphy

CONTACT

8663371868; p.murphy@crmg-usa.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: February 14, 2025
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): June 30, 2032
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)