The study will aim to find out if the drug andexanet alfa is safe and effective in preventing major bleeding during urgent surgery or invasive procedures. The study will compare the use of andexanet alfa to the usual care given at the study center.
This study will be an open-label, randomised, controlled, prospective, multicenter study. The study will include patients requiring urgent surgery or procedure that needs to be performed within 15 hours of the last dose of blood-thinning drug (direct oral activated Factor X (FXa) inhibitor). The study will comprise of the following periods: * Screening, followed by surgery or procedure and study intervention. * Follow-up period: there will be four follow-up visits over a duration of approximately 30 days. * Follow-up visit for patients with positive anti-andexanet alfa antibody test: patients with a positive anti-andexanet alfa antibody response at day 30 will have a follow-up anti-andexanet alfa antibody test approximately 120 days post-surgery or procedure. Patients will be randomised in the ratio of 1:1 to receive either andexanet alfa or usual care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Andexanet is a recombinant version of human FXa
As per the label of the chosen usual care product(s) and/or usual care standards.
Number of patients achieving effective intraoperative hemostasis
Intraoperative hemostasis will be assessed according to the categories as per 4-point hemostasis scale: Excellent - Normal hemostasis, Good - Mildly abnormal hemostasis (eg. slight oozing from surgical wounds), Moderate - Moderate abnormality in intraprocedural hemostasis (eg. controllable bleeding), Poor - Severe hemostatic abnormality (eg. severe refractory hemorrhage). Hemostasis will be considered to be effective if the intraoperative hemostasis category is 'excellent' or 'good', and ineffective if the intraoperative hemostasis category is 'moderate' or 'poor'.
Time frame: From start to the end of surgery or procedure on Day 0
Change from Baseline in anti-FXa activity measured through blood samples
The ability of andexanet alfa to rapidly reverse the anticoagulation effect of FXa inhibitors by reduction of anti-FXa activity when compared to usual care.
Time frame: Baseline to start of surgery or procedure
Change from Baseline in anti-FXa activity measured through blood samples
The ability of andexanet alfa to sustainably reverse the anticoagulation effect of FXa inhibitors by reduction of anti-FXa activity when compared to usual care at two hours post start of surgery or procedure will be assessed.
Time frame: Baseline to two hours post start of surgery or procedure
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