Safety and Effectiveness Study of Non-immunogenic Staphylokinase for Massive Pulmonary Embolism Treatment

What this Trial Is About

This research aims to study the safety and effectiveness of a drug called non-immunogenic staphylokinase in patients with massive pulmonary embolism, a serious condition involving blood clots in the lungs. The study builds on previous trials that found this drug to be as effective as alteplase with fewer major bleeding events, making it a promising emergency treatment option. The study is observational and focuses on patients receiving this drug in routine clinical practice. Participants receive a single intravenous bolus dose of 15 mg non-immunogenic staphylokinase Fortelyzin4 regardless of body weight. This drug is easy to administer quickly in emergency situations and is used for treating massive pulmonary embolism since 2024. The study collects information on patients treated with this drug to assess outcomes in a real-world setting. During the study, participants are monitored for outcomes such as all-cause mortality at 7 and 30 days after drug administration, hemodynamic collapse, recurrent pulmonary embolism, and pulmonary artery systolic pressure changes. Safety is closely observed, especially for bleeding events. The study runs from June 2025 to December 2027, with ongoing evaluation of participants following treatment in routine care.

Post-registration Trial of the Non-immunogenic Staphylokinase in Massive Pulmonary Embolism