VALIdation of a Treatment Decision Pathway for Andexanet Alfa
Recruiting
- Conditions
- Anticoagulation reversal for major bleeding or emergency surgery in patients taking direct oral factor Xa inhibitors.
- Registration Number
- DRKS00033444
- Lead Sponsor
- GWT-TUD GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 600
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
patients not fulfilling inclusion criteria
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method • Estimation of proportion (%) of patients in category C<br>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