Major Bleeding
Conditions
Keywords
real-world evidence, Factor Xa inhibitor treatment, reversal/replacement therapy
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.
Interventions
OTHERNone (Observational study)
Not Applicable since Observational Study
Sponsors
Parexel
AstraZeneca
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 130 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| 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. |
| 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. |
| 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 (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 (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 (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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
Countries
Germany, Japan, United Kingdom, United States
Outcome results
None listed