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

Not yet recruiting

• Conditions: Significant Bleeding Risk; Vitamin K-Dependent Coagulation Defect
• Interventions: Drug: Balfaxar; Drug: Kcentra

• Registration Number: NCT06429787
• Lead Sponsor: Octapharma

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-21
• Study First Submitted QC: 2024-05-21
• Last Update Submitted: 2024-05-21
• Study First Posted: 2024-05-28
• Last Update Posted: 2024-05-28
• Study Start: 2024-06-30
• Primary Completion: 2031-12-31
• Study Completion: 2032-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3574

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BALFAXAR® (500 IU)	Balfaxar	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
Kcentra® (500 IU)	Kcentra	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.

Primary Outcome Measures

Name	Time	Method
TEEs within 45 days following VKA reversal treatment	45 days	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.

Secondary Outcome Measures

Name	Time	Method
TEEs within 7 and 14 days following VKA reversal treatment	14 days	Proportion of subjects diagnosed with TEEs within 7 and 14 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.
Median Time to TEEs	45 days	Median time to TEE following administration of BALFAXAR compared to median time to TEE following administration of Kcentra
All Cause Mortality	45 days	Proportion of subjects who die from any reason within 7, 14 and 45 days following VKA reversal treatment with BALFAXAR compared to proportion of subjects who die from any reason within the same time period following treatment with Kcentra.
Median Time to All Cause Mortality	45 days	Median time to death following administration of BALFAXAR compared to median time to death following administration of Kcentra
Rate of Fatal TEEs	45 days	Rate of fatal TEEs following treatment with BALFAXAR compared to rate of fatal TEEs following treatment with Kcentra within 7, 14 and 45 days following VKA reversal treatment