Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor

• Status: Recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicentre, prospective, randomised, double-blinded, group-sequential, parallel-group, adaptive design, phase 3 study to demonstrate the haemostatic efficacy and safety of four-factor prothrombin complex concentrate, OCTAPLEX, in patients with acute major bleeding on DOAC therapy with factor Xa inhibitor. Patients will be randomised 1:1 to either of two study groups: low-dose vs. high-dose OCTAPLEX.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Octapharma

Criteria

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