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

Octapharma

Status: Enrolling

Conditions: Significant Bleeding Risk; Vitamin K-Dependent Coagulation Defect

Treatments: Drug: Kcentra; Drug: Balfaxar

Study type: Observational

Funder types: Industry

Identifiers

NCT06429787

LEX-212

Details and patient eligibility

About

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

Enrollment: 3,574 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

3,574 participants in 2 patient groups

BALFAXAR® (500 IU)

Description:

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

Treatment:

Drug: Balfaxar

Kcentra® (500 IU)

Description:

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.

Treatment:

Drug: Kcentra