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NCT Number: 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

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.

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Key information

Conditions

Major Bleeding

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Aachen, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

None (Observational study)

Other

Not Applicable since Observational Study

Other names: Observational Study

Primary outcomes

  1. Demographics (age in years)

    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)

    Summary statistics will be used to describe demographics.

  2. Demographics (sex)

    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)

    Summary statistics will be used to describe demographics.

  3. Demographics (ethnicity)

    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)

    Summary statistics will be used to describe demographics.

  4. Demographics (race)

    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)

    Summary statistics will be used to describe demographics.

  5. Demographics (payer type)

    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)

    Summary statistics will be used to describe demographics.

  6. Clinical presentation

    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)

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

  7. Healthcare interventions provided during acute care phase

    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)

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

  8. In-hospital outcomes

    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)

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

  9. Timing of administration of reversal/replacement agents since 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)

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

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

    Time frame: 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.

  11. 5-Dimension Health Questionnaire 5 Level (EQ-5D-5L) - Cohort B

    Time frame: 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 outcomes

  1. Clinical outcomes - Cohort B

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  4. 5-Dimension Health Questionnaire 5 Level (EQ-5D-5L) - Cohort B

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Parexel

Registry information

Official study title

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

Acronym: REVERXaL

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 28, 2023
Registry last updated
Nov 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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