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

Major Bleeding Clinical Trial

— REVERXaL  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06147830
• Other study ID #: D9603R00003
• Status: Recruiting
• Start date: December 4, 2023
• Est. completion date: March 11, 2025

Study information

• Verified date: May 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: March 11, 2025
• Est. primary completion date: March 11, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hemorrhage
• Major Bleeding

Intervention

Other:
• None (Observational study)
Not Applicable since Observational Study

Locations

Country	Name	City	State
Germany	Research Site	Altenburg
Germany	Research Site	Bad Neustadt/Saale
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Bochum
Germany	Research Site	Bonn
Germany	Research Site	Dortmund
Germany	Research Site	Dresden
Germany	Research Site	Jena
Germany	Research Site	Koblenz
Germany	Research Site	Köln
Germany	Research Site	Leipzig
Germany	Research Site	Lübeck
Germany	Research Site	Ludwigshafen am Rhein
Germany	Research Site	Lüneburg
Germany	Research Site	Osnabrück
Germany	Research Site	Potsdam
Germany	Research Site	Saarbrücken
Germany	Research Site	Trier
Japan	Research Site	Asahikawa
Japan	Research Site	Hitachi
Japan	Research Site	Izumo
Japan	Research Site	Kagoshima
Japan	Research Site	Kitakyushu
Japan	Research Site	Kyoto
Japan	Research Site	Mitaka
Japan	Research Site	Saga
Japan	Research Site	Shimotsuke
Japan	Research Site	Suita
Japan	Research Site	Tachikawa
Japan	Research Site	Tokyo
United Kingdom	Research Site	Aberdeen
United Kingdom	Research Site	Bournemouth
United Kingdom	Research Site	Canterbury
United Kingdom	Research Site	Cardiff
United Kingdom	Research Site	Edgbaston
United Kingdom	Research Site	Harrow
United Kingdom	Research Site	Liverpool
United Kingdom	Research Site	London
United Kingdom	Research Site	Oxford
United Kingdom	Research Site	Preston
United Kingdom	Research Site	Sheffield
United Kingdom	Research Site	Southampton
United States	Research Site	Columbus	Ohio
United States	Research Site	Kansas City	Kansas
United States	Research Site	Lexington	Kentucky
United States	Research Site	New Hyde Park	New York
United States	Research Site	Orange	California
United States	Research Site	Royal Oak	Michigan
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Stony Brook	New York
United States	Research Site	Torrance	California

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Parexel

Countries where clinical trial is conducted

United States,  Germany,  Japan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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.	At 30 days post index (date of administration of reversal/replacement agents)
Secondary	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.	At 30 days post index (date of administration of reversal/replacement agents)
Secondary	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.	30 days post index (date of administration of reversal/replacement agents)
Secondary	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).	30 days post index (date of administration of reversal/replacement agents)