Study of Four-factor Prothrombin Complex Concentrate, OCTAPLEX, in Patients With Acute Major Bleeding on Direct Oral Anticoagulant (DOAC) Therapy With Factor Xa Inhibitor
Octapharma
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients on oral factor Xa inhibitor therapy and with known or suspected baseline anti-factor Xa activity of at least 100 ng/mL: \- Patients who received or who are believed by the investigator to have received a dose of oral factor Xa inhibitor and who have a baseline anti- factor Xa activity of at least 100 ng/mL according to the locally available test (e.g., chromogenic assay) performed outside of the study as part of standard of care OR * Patients who received or who are believed by the investigator to have received their latest dose of oral factor Xa inh…
Interventions
- DrugOctaplex
Four-factor prothrombin complex concentrate (4F-PCC)
Locations (63)
- Harbor-UCLA Medical CenterTorrance, California
- The University of FloridaGainesville, Florida
- St. Mary's Medical CenterWest Palm Beach, Florida
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Hennepin County Medical CenterMinneapolis, Minnesota
- University of Mississippi Medical CenterJackson, Mississippi