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:
Participant gender:
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.