NCT06429787 - 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 | Biotech Hunter

Enrollment

3,574

Participants

Timeline

Start Date

February 14, 2025

Primary Completion Date

December 31, 2031

Study Completion Date

June 30, 2032

Conditions

Vitamin K-Dependent Coagulation DefectSignificant Bleeding Risk

Interventions

DRUG

Balfaxar

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

DRUG

Kcentra

"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"

Trial Locations (1)

02215

RECRUITING

Octapharma Research Site, Boston