Safety and Effectiveness Study of Ondexxya 200 mg Intravenous Injection in Patients with Life-Threatening Bleeding on Factor Xa Inhibitors

What this Trial Is About

Researchers are conducting a survey to study patients who have received Ondexxya Intravenous Injection 200 mg to neutralize the anticoagulant effects of Factor Xa inhibitors during life-threatening or unarrestable bleeding episodes. This observational study aims to monitor safety specifications such as thrombotic events, infusion reactions, and re-bleeding, while also understanding the drugs safety and effectiveness under real-world use. The survey collects information about the occurrence of unknown adverse drug reactions, the incidence of adverse reactions during routine use, and factors that might influence the drugs safety or effectiveness. There are no specific treatments or interventions administered as part of the study since it observes patients receiving routine care with Ondexxya. Participants will be monitored for 30 days to document adverse drug reactions and safety-related events, including how patient background factors may affect outcomes. Data collection involves safety and effectiveness information gathered during this period, with no additional procedures or visits beyond standard clinical care. The study is sponsored by AstraZeneca and will continue until October 2026.

Ondexxya for Intravenous Injection 200mg Drug Use Result Investigation (All Case Investigation)