Anticoagulation reversal for major bleeding or emergency surgery in patients taking direct oral factor Xa inhibitors.
Conditions
Interventions
Group 1: Single arm cohort of patients with acute life-threatening dXI (bleeding) emergencies and available data for routine laboratoy and specific calibrated anti-Xa activity on admission
Sponsors
GWT-TUD GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 2) objectively confirmed acute and life-threating emergency in patients reported to be taking dXI • at least 80% of the emergencies included need to be bleeding emergencies • up to 20% of patients with emergency surgery are allowed 3) availability of specific and calibrated anti-Xa levels from blood samples obtained within 6 hours after admission AND obtained before reversal with Andexanet Alfa (if used) 4) availability of routine blood tests (blood count, eGFR, aPTT, prothrombin time, INR) from blood samples obtained within 90 minutes after admission
Exclusion criteria
Exclusion criteria: patients not fulfilling inclusion criteria
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| • Estimation of proportion (%) of patients in category C Estimation of the difference between true door-to-decision time (as it was achieved in clinical care) and potential door-to-decision time (if algorithm would have been applied) to estimate potential for time-saving from algorithm applicatio | — |
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the VALIDA trial is the validation (and adjustment, if applicable) of a treatment decision algorithm for andexanet alfa use in acute life-threatening bleeding emergencies in patients taking direct oral factor Xa inhibitors (dXI). | — |
Countries
Germany
Contacts
Public ContactJan Beyer-Westendorf
Universitätsklinikum Carl Gustav Carus Dresden
Outcome results
None listed