This clinical trial is focused on studying a treatment for patients experiencing acute major bleeding while on a specific type of blood thinner known as a direct oral anticoagulant (DOAC) that works by inhibiting factor Xa. The treatment being tested is called OCTAPLEX, which is a four-factor prothrombin complex concentrate. This treatment contains several important proteins, including human coagulation factors IX, II, VII, and X, as well as protein C and protein S. These proteins are essential for blood clotting and are used to help reverse the effects of the blood thinner in emergency situations.

The purpose of the study is to evaluate the effectiveness of OCTAPLEX in stopping major bleeding in patients who are taking a factor Xa inhibitor. Participants in the study will receive different doses of OCTAPLEX to determine which dose is more effective in managing the bleeding. The study will involve monitoring patients for a short period after receiving the treatment to observe any changes in their condition and to ensure their safety.

Throughout the study, researchers will assess the treatment’s ability to control bleeding and will also monitor for any side effects or complications. The study aims to provide valuable information on how to best manage bleeding in patients taking DOACs, ultimately improving care for those who experience this serious condition.