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

AstraZeneca

Status: Completed

Conditions: Major Bleeding

Treatments: Other: None (Observational study)

Study type: Observational

Funder types: Industry

Identifiers

NCT06147830

D9603R00003

Details and patient eligibility

About

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.

Full 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 nature without any pre-specified statistical hypotheses. Variables will be collected according to routine medical practice either through primary data collection directly from patients, or from secondary data collection via data extraction from electronic or paper medical records into electronic case report forms (eCRFs). Patients will undergo clinical assessments and receive standard medical care as determined by their treating physicians. Patients will not receive any experimental disease management intervention or experimental treatment because of their participation in the study. As part of routine care, study investigators will evaluate patients about their medical history, medication history, bleeding presentation, and any adverse event (AE) or severe adverse event (SAE) experiences since the previous clinical visit and the related information. No additional or pre-defined site visits will be scheduled outside of the patient's routine clinical visits.

Enrollment: 2,202 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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)

Trial design

2,202 participants in 2 patient groups

Cohort A - Historical Cohort

Description:

Cohort A will comprise of approximately 2000 patients admitted for major bleedings in the presence of Factor Xa inhibitor treatment during a defined period (up to 2 years prior to commencing enrolment of patients in Cohort B). Patients who developed major bleeding in the presence of Factor Xa inhibitor treatment while already admitted in hospitals will also be included. Patients may or may not have received a reversal/replacement therapy. Patients are followed in medical charts from admission to discharge.

Treatment:

Other: None (Observational study)

Cohort B - Prospective Cohort

Description:

Cohort B will enrol approximately 2000 patients who were administered any reversal or replacement agent during the acute care phase for a major bleeding in the presence of Factor Xa inhibitor treatment at the participating sites. Patients will be followed up to three months after administration of reversal or replacement therapy.

Treatment:

Other: None (Observational study)