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

Octapharma3,574 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

3,574

Conditions

Vitamin K-Dependent Coagulation Defect Significant Bleeding Risk

Interventions

BalfaxarDRUG

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

KcentraDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Octapharma Research Site

Boston, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 45 days

Secondary Outcomes

TEEs within 7 and 14 days following VKA reversal treatment

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.

Time frame: 14 days

Median Time to TEEs

Median time to TEE following administration of BALFAXAR compared to median time to TEE following administration of Kcentra

Time frame: 45 days

All Cause Mortality

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.

Time frame: 45 days

Median Time to All Cause Mortality

Median time to death following administration of BALFAXAR compared to median time to death following administration of Kcentra

Time frame: 45 days

Rate of Fatal TEEs

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

Time frame: 45 days

Central Contacts

Patrick Murphy

CONTACT

8663371868 p.murphy@crmg-usa.com

Data from ClinicalTrials.gov

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