A Study to Describe the Characteristics, Health Care Interventions and Outcomes of Patients With Major Bleedings in the Presence of Factor Xa Inhibitor Treatment
- Conditions
- Major Bleeding
- Interventions
- Other: None (Observational study)
- Registration Number
- NCT06147830
- Lead Sponsor
- AstraZeneca
- 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 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.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2219
- 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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort A - Historical Cohort None (Observational study) 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. Cohort B - Prospective Cohort None (Observational study) 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.
- Primary Outcome Measures
Name Time Method Demographics (race) Cohort A: from admission for the bleeding (index date) until hospital discharge. Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days) Summary statistics will be used to describe demographics.
Clinical presentation Cohort A: from admission for the bleeding (index date) until hospital discharge. Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days) Summary statistics will be used to describe clinical presentation of patients.
In-hospital outcomes Cohort A: from admission for the bleeding (index date) until hospital discharge. Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days) To describe the in-hospital outcomes in patients with major bleedings in the context of Factor Xa inhibitor treatment.
Demographics (sex) Cohort A: from admission for the bleeding (index date) until hospital discharge. Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days) Summary statistics will be used to describe demographics.
Demographics (age in years) Cohort A: from admission for the bleeding (index date) until hospital discharge. Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days) Summary statistics will be used to describe demographics.
Demographics (ethnicity) Cohort A: from admission for the bleeding (index date) until hospital discharge. Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days) Summary statistics will be used to describe demographics.
Demographics (payer type) Cohort A: from admission for the bleeding (index date) until hospital discharge. Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days) Summary statistics will be used to describe demographics.
Healthcare interventions provided during acute care phase Cohort A: from admission for the bleeding (index date) until hospital discharge. Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days) To describe the health care interventions provided during acute care phase in patients with major bleedings in the context of Factor Xa inhibitor treatment.
Timing of administration of reversal/replacement agents since admission/bleed onset Cohort A: from admission for the bleeding (index date) until hospital discharge. Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days) To describe the timing of administration of reversal/replacement agents from admission/bleed onset.
Short Form Health Survey (SF-36) - Cohort B Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days) The 36-Item Short Form Health Survey Version 2 (SF-36 v2) is a standardized, patient-administered instrument across eight domains (including physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health). Each subscale is scored separately, and the scores range from 0 to 100. Higher scores indicate better health-related quality of life.
5-Dimension Health Questionnaire 5 Level (EQ-5D-5L) - Cohort B Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days) The EuroQoL EQ-5D-5L questionnaire measures generic Health-Related Quality of Life (HRQoL) and contains questions on five dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety/depression. Each subscale is scored based on 5 levels of severity (no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems). It can be converted into a single numeric score and has been translated and validated in numerous countries. The EQ-5D-5L scoring system assigns a utility value to each health state based on population preferences. The utility values range from -0.594 (representing the worst health state possible) to 1.000 (representing perfect health).
- Secondary Outcome Measures
Name Time Method Clinical outcomes - Cohort B At 30 days post index (date of administration of reversal/replacement agents) To describe the clinical outcomes in patients who experienced major bleedings in the context of Factor Xa inhibitor treatment and administered reversal/replacement therapy.
Timing of administration of reversal/replacement therapy since admission/bleed onset - Cohort B At 30 days post index (date of administration of reversal/replacement agents) To describe the timing of administration of reversal replacement therapy since admission/bleed onset.
Short Form Health Survey (SF-36) - Cohort B 30 days post index (date of administration of reversal/replacement agents) The 36-Item Short Form Health Survey Version 2 (SF-36 v2) is a standardized, patient-administered instrument across eight domains (including physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Each subscale is scored separately, and the scores range from 0 to 100. Higher scores indicate better health-related quality of life.
5-Dimension Health Questionnaire 5 Level (EQ-5D-5L) - Cohort B 30 days post index (date of administration of reversal/replacement agents) The EuroQoL EQ-5D-5L questionnaire measures generic HRQoL and contains questions on five dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety/depression. Each subscale is scored based on 5 levels of severity (no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems). It can be converted into a single numeric score and has been translated and validated in numerous countries. The EQ-5D-5L scoring system assigns a utility value to each health state based on population preferences. The utility values range from -0.594 (representing the worst health state possible) to 1.000 (representing perfect health).
Trial Locations
- Locations (1)
Research Site
🇬🇧Southampton, United Kingdom