Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

A Study to Describe the Characteristics, Health Care Interventions and Outcomes of Patients With Major Bleedings in the Presence of Factor Xa Inhibitor Treatment
A Study to Describe the Characteristics, Health Care Interventions and Outcomes of Patients With Major Bleedings in the Presence of Factor Xa Inhibitor Treatment

NCT06147830

CompletedN/A

Sponsor: AstraZeneca

Conditions: Major Bleeding

Interventions: None (Observational study)

Countries: United States, Germany, Japan, United Kingdom

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 of patients with major bleeding in the presence of Factor Xa inhibitor treatment. The generation of insight on treatment approaches and associated outcomes in hospitalized patients with Factor Xa inhibitor-related major bleeds may inform clinical guidelines, health system decision making and streamline treatment pathways in this population.

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* 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)
Locations (75)
  • Chandler, Arizona, United States
  • Orange, California, United States
  • Sacramento, California, United States
  • Torrance, California, United States
  • Lakewood, Colorado, United States
  • Hartford, Connecticut, United States
  • Orlando, Florida, United States
  • Tampa, Florida, United States
  • Glenview, Illinois, United States
  • Kansas City, Kansas, United States
  • Lexington, Kentucky, United States
  • Royal Oak, Michigan, United States
  • Kansas City, Missouri, United States
  • St Louis, Missouri, United States
  • Albany, New York, United States
  • New Hyde Park, New York, United States
  • Staten Island, New York, United States
  • Stony Brook, New York, United States
  • Valhalla, New York, United States
  • Chapel Hill, North Carolina, United States
  • Columbus, Ohio, United States
  • Toledo, Ohio, United States
  • Portland, Oregon, United States
  • Dallas, Texas, United States
  • Milwaukee, Wisconsin, United States
  • Aachen, Germany
  • Altenburg, Germany
  • Bad Neustadt/Saale, Germany
  • Berlin, Germany
  • Bochum, Germany
  • + 45 more on CT.gov