Status:
COMPLETED
A Study to Describe the Characteristics, Health Care Interventions and Outcomes of Patients With Major Bleedings in the Presence of Factor Xa Inhibitor Treatment
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Parexel
Conditions:
Major Bleeding
Eligibility:
All Genders
18-130 years
Brief Summary
REVERXaL study aims to increase the understanding of the patient characteristics, bleeding presentation, health care interventions provided, and the clinical as well as self-reported health outcomes o...
Detailed Description
REVERXaL is a multinational observational study incorporating 2 patient cohorts (historical and prospective) with major bleeds during Factor Xa inhibitor use. This study will be mainly descriptive in ...
Eligibility Criteria
Inclusion
- Aged ≥18 years on the index date
- Admitted to the hospital with an acute major bleeding or developed an acute bleeding while already in hospital
- Ongoing treatment with a Factor Xa inhibitor before the index date
- Provided signed and dated informed consent or able to obtain a waiver
- In addition, for cohort B:
- \- Administered reversal or replacement therapy
Exclusion
- Pregnant women
- Patients enrolled in any interventional trial that includes reversal/replacement agents
- In addition, for cohort B:
- Use of vitamin K antagonists, dabigatran, prothrombin complex concentrates or recombinant factor VII, or transfusion of whole blood or plasma within the preceding 7 days of the index event
- As judged by the investigator, if it is deemed undesirable for the patient to participate in the study or participant is unlikely to comply with study procedures, and requirements
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
Key Trial Info
Start Date :
December 4 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2024
Estimated Enrollment :
2202 Patients enrolled
Trial Details
Trial ID
NCT06147830
Start Date
December 4 2023
End Date
November 30 2024
Last Update
November 3 2025
Active Locations (75)
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1
Research Site
Chandler, Arizona, United States, 85224
2
Research Site
Orange, California, United States, 92868
3
Research Site
Sacramento, California, United States, 95817
4
Research Site
Torrance, California, United States, 90509