Study to demonstrate the efficacy and safety of OCTAPLEX in patients with acute major bleeding that are taking direct oral anticoagulant.

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 200

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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

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 the preceding 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
• Patients scheduled to undergo surgery in less than 12 hours, with the exception of some minor/invasive procedures that are allowed for diagnostic or therapeutic reasons (see Section 4.1.2)
• Patients who are pregnant or breastfeeding at the time of enrolment
• Patients previously enrolled in this study
• Patients participating in another interventional clinical treatment study currently or during the past 1 month prior to study inclusion

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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