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

NCT06147830 | Completed

• 1 other identifier: D9603R00003
• Study Type: observational
• Target: 2,202
• Locations: 4 countries
• Sites: 75

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.

Conditions

Major Bleeding

Keywords

real-world evidence; Factor Xa inhibitor treatment; reversal/replacement therapy

Outcome Measures

Primary Outcomes (11)

• Demographics (age in years)

  Summary statistics will be used to describe demographics.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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).

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

Secondary Outcomes (4)

• Clinical outcomes - Cohort B

  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

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

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

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

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

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

Study Arms (2)

Cohort A - Historical Cohort

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.

Other: None (Observational study)

Cohort B - Prospective Cohort

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.

Other: None (Observational study)

Interventions

None (Observational study) OTHER

Not Applicable since Observational Study

Also known as: Observational Study

Cohort A - Historical Cohort; Cohort B - Prospective Cohort

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients aged ≥18 years admitted to hospital with an acute major bleeding or developed an acute bleeding while already in hospital and received ongoing treatment with a Factor Xa inhibitor before the index date.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (75)

Research Site

Chandler, Arizona, 85224, United States

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Orange, California, 92868, United States

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Sacramento, California, 95817, United States

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Torrance, California, 90509, United States

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Lakewood, Colorado, 80228-1527, United States

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Hartford, Connecticut, 06102, United States

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Orlando, Florida, 32803, United States

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Tampa, Florida, 33606, United States

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Glenview, Illinois, 60026, United States

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Kansas City, Kansas, 66160, United States

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Lexington, Kentucky, 40536, United States

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Royal Oak, Michigan, 48073, United States

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Kansas City, Missouri, 64111, United States

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St Louis, Missouri, 63110, United States

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Albany, New York, 12208, United States

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New Hyde Park, New York, 11040, United States

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Staten Island, New York, 10305, United States

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Stony Brook, New York, 11794, United States

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Valhalla, New York, 10595, United States

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Chapel Hill, North Carolina, 27514, United States

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Columbus, Ohio, 43210, United States

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Toledo, Ohio, 43614, United States

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Portland, Oregon, 97201-3098, United States

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Dallas, Texas, 75390, United States

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Milwaukee, Wisconsin, 53226, United States

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Aachen, Germany

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Altenburg, Germany

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Bad Neustadt/Saale, Germany

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Berlin, Germany

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Bochum, Germany

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Bonn, Germany

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Cologne, Germany

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Dortmund, Germany

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Dresden, Germany

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Essen, Germany

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G Ppingen, Germany

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Jena, Germany

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Koblenz, Germany

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L Beck, Germany

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L Neburg, Germany

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Leipzig, Germany

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Ludwigshafen am Rhein, Germany

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Osnabr Ck, Germany

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Potsdam, Germany

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Trier, Germany

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Tübingen, Germany

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Würzburg, Germany

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Asahikawa, Japan

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Fukuoka, Japan

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Hitachi, Japan

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Izumo, Japan

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Kagoshima, Japan

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Kamakura, Japan

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Kitakyushu, Japan

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Kyoto, Japan

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Mitaka, Japan

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Nagakute, Japan

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Okayama, Japan

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Saga, Japan

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Shimotsuke, Japan

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Suita, Japan

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Tachikawa, Japan

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Tokyo, Japan

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Aberdeen, United Kingdom

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Bournemouth, United Kingdom

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Canterbury, United Kingdom

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Cardiff, United Kingdom

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Edgbaston, United Kingdom

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Harrow, United Kingdom

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Liverpool, United Kingdom

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London, United Kingdom

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Oxford, United Kingdom

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Preston, United Kingdom

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Sheffield, United Kingdom

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Southampton, United Kingdom

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Related Publications (1)

• Alikhan R, Nour M, Yasaka M, Ofori-Asenso R, Axelsson-Cheramy S, Chen H, Seghal V, Yokobori S, Koch B, Tiede A, Cash BD, Maegele M, Singer AJ. Design and rationale for REVERXaL: A real-world study of patients with factor Xa inhibitor-associated major bleeds. Thromb Res. 2024 Aug;240:109046. doi: 10.1016/j.thromres.2024.109046. Epub 2024 Jun 5.

  PMID: 38905928 DERIVED

Related Links

• Redacted CSR synopsis

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: November 28, 2023
• Study Start: December 4, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

US (25); GB (12); JP (16); DE (22)