Clinical trial 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
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Bleeding
Keywords: real-world evidence
Factor Xa inhibitor treatment
reversal/replacement therapy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2023-11-28
Enrollment: 2219
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Demographics (age in years)
timeFrame: 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)
measure: Demographics (sex)
timeFrame: 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)
measure: Demographics (ethnicity)
timeFrame: 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)
measure: Demographics (race)
timeFrame: 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)
measure: Demographics (payer type)
timeFrame: 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)
measure: Clinical presentation
timeFrame: 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)
measure: Healthcare interventions provided during acute care phase
timeFrame: 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)
measure: In-hospital outcomes
timeFrame: 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)
measure: Timing of administration of reversal/replacement agents since admission/bleed onset
timeFrame: 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)
measure: Short Form Health Survey (SF-36) - Cohort B
timeFrame: Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days)
measure: 5-Dimension Health Questionnaire 5 Level (EQ-5D-5L) - Cohort B
timeFrame: Cohort B: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days)
Secondary outcomes:
measure: Clinical outcomes - Cohort B
timeFrame: At 30 days post index (date of administration of reversal/replacement agents)
measure: Timing of administration of reversal/replacement therapy since admission/bleed onset - Cohort B
timeFrame: At 30 days post index (date of administration of reversal/replacement agents)
measure: Short Form Health Survey (SF-36) - Cohort B
timeFrame: 30 days post index (date of administration of reversal/replacement agents)
measure: 5-Dimension Health Questionnaire 5 Level (EQ-5D-5L) - Cohort B
timeFrame: 30 days post index (date of administration of reversal/replacement agents)
Other outcomes:
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Study officials:
References: