Acute major bleeding in patients receiving DOAC therapy with factor Xa inhibitor
Conditions
Brief summary
The proportion of patients in whom OCTAPLEX demonstrates haemostatic effectiveness, i.e., binary outcome of effective (rating of excellent or good) or non-effective (rating of poor/none) in management of major bleeding events.
Detailed description
Change in endogenous thrombin potential (ETP) as measured by thrombin generation assay (TGA) from baseline to 1 hour after OCTAPLEX administration, 30-day event rate of thromboembolic events (TEEs) and all-cause mortality, Occurrence of adverse events (AEs) during a 48-hours follow up period after OCTAPLEX administration, Vital signs and laboratory parameters during a 48-hours follow up period after OCTAPLEX administration
Interventions
DRUGOctaplex 500 I.E. Pulver und Lösungsmittel zur Herstellung einer Infusionslösung
DRUGOctaplex 1000 I.E. Pulver und Lösungsmittel zur Herstellung einer Infusionslösung
Sponsors
Octapharma AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients in whom OCTAPLEX demonstrates haemostatic effectiveness, i.e., binary outcome of effective (rating of excellent or good) or non-effective (rating of poor/none) in management of major bleeding events. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in endogenous thrombin potential (ETP) as measured by thrombin generation assay (TGA) from baseline to 1 hour after OCTAPLEX administration, 30-day event rate of thromboembolic events (TEEs) and all-cause mortality, Occurrence of adverse events (AEs) during a 48-hours follow up period after OCTAPLEX administration, Vital signs and laboratory parameters during a 48-hours follow up period after OCTAPLEX administration | — |
Countries
Austria, Croatia, Germany, Italy, Poland, Spain
Outcome results
None listed