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

N/ACompletedNCT06147830

AstraZeneca2,202 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

2,202

Conditions

Interventions

Outcomes

Primary Outcomes

Demographics (age in years)

Summary statistics will be used to describe demographics.

Time frame: 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)

Demographics (sex)

Summary statistics will be used to describe demographics.

Time frame: 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)

Demographics (ethnicity)

Summary statistics will be used to describe demographics.

Time frame: 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)

Demographics (race)

Summary statistics will be used to describe demographics.

Time frame: 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)

Demographics (payer type)

Summary statistics will be used to describe demographics.

Time frame: 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)

Clinical presentation

Summary statistics will be used to describe clinical presentation of patients.

Time frame: 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)

Healthcare interventions provided during acute care phase

To describe the health care interventions provided during acute care phase in patients with major bleedings in the context of Factor Xa inhibitor treatment.

Time frame: 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)

In-hospital outcomes

To describe the in-hospital outcomes in patients with major bleedings in the context of Factor Xa inhibitor treatment.

Time frame: 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)

Timing of administration of reversal/replacement agents since admission/bleed onset

To describe the timing of administration of reversal/replacement agents from admission/bleed onset.

Time frame: 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)

Short Form Health Survey (SF-36) - Cohort B

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.

Time frame: Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days)

5-Dimension Health Questionnaire 5 Level (EQ-5D-5L) - Cohort B

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).

Time frame: Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days)

Secondary Outcomes

Clinical outcomes - Cohort B

To describe the clinical outcomes in patients who experienced major bleedings in the context of Factor Xa inhibitor treatment and administered reversal/replacement therapy.

Time frame: At 30 days post index (date of administration of reversal/replacement agents)

Timing of administration of reversal/replacement therapy since admission/bleed onset - Cohort B

To describe the timing of administration of reversal replacement therapy since admission/bleed onset.

Time frame: At 30 days post index (date of administration of reversal/replacement agents)

Short Form Health Survey (SF-36) - Cohort B

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.

Time frame: 30 days post index (date of administration of reversal/replacement agents)

5-Dimension Health Questionnaire 5 Level (EQ-5D-5L) - Cohort B

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).

Time frame: 30 days post index (date of administration of reversal/replacement agents)

NCT06147830 - A Study to Describe the Characteristics, Health Care Interventions and Outcomes of Patients With Major Bleedings in the Presence of Factor Xa Inhibitor Treatment | Crick | Crick