Inclusion Criteria:  Patients who received or who are believed by the investigator to have received a dose of oral factor Xa inhibitor Aged ≥18 years Patients who have given written informed consent or for whom written informed consent has been obtained from the patient's legally authorised representative on their behalf  Patients who have acute major bleeding defined as follows:  Bleeding that is potentially life-threatening or uncontrolled, e.g., with signs or symptoms of haemodynamic compromise, such as severe hypotension, poor skin perfusion, or low cardiac output that cannot be otherwise explained OR Symptomatic bleeding in critical organs (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome) OR Acute overt bleeding associated with a fall in haemoglobin (Hgb) level of ≥2 g/dL, OR a Hgb level ≤8 g/dL if no baseline Hgb level is available, OR in the opinion of the investigator that the patient's Hgb level will fall to ≤8 g/dL with resuscitation Patients with baseline anti-factor Xa activity equivalent to at least 100 ng/mL according to the available test (e.g., chromogenic assay)  Exclusion Criteria:  Patients with bleeding that is immediately life-threatening Patients with 'Do not resuscitate' (DNR) orders Patients with acute trauma for which reversal of DOAC therapy with factor Xa inhibitor alone would not be expected to control the bleeding event Hgb decrease without accompanying evidence of source of bleeding Acute coronary syndrome, ischaemic stroke or venous thromboembolism (VTE) within 3 months Patients with a history, within the last 3 months, of disseminated intravascular coagulation (DIC) or hyperfibrinolysis Patients with a known congenital coagulation disorder Known inhibitors to coagulation factors II, VII, IX, or X; or heparin-induced, type II thrombocytopenia Known hypersensitivity to plasma-derived products Patients who received haemostatic agents, including plasma, platelets, PCC, activated PCC (aPCC), recombinant factor VIIa, or recombinant factor Xa inactivated-zhzo (andexanet alfa), for the current bleeding event prior to enrolment (antifibrinolytic drugs and local haemostatic agents are allowed) Patients who received clopidogrel within 5 days or prasugrel within 7 days or ticagrelor within the 48 hours preceding the bleeding event Patients on enoxaparin therapy for thromboembolic prophylaxis A score of less than 7 on the Glasgow Coma Scale or an estimated intracerebral haematoma volume of more than 60 mL Patients with expected survival of less than 3 days