REVERXaL
Research type
Research Study
Full 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
IRAS ID
339289
Contact name
Raza Alikhan
Contact email
Sponsor organisation
AstraZeneca
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
This study aims to gather important information about patients who experience major bleeding while being treated with FXa inhibitors. Currently, there is limited real-world data available outside of clinical trials on this topic. Previous trials have only followed patients for about a month after the bleeding event. To bridge this knowledge gap, the study seeks to explore patient characteristics, healthcare interventions during hospitalization for major bleeding, as well as outcomes after discharge for patients on FXa inhibitors.
To achieve this, the study will be conducted as a multinational, observational, longitudinal cohort study. Two cohorts will be included, each consisting of approximately 2000 patients. Cohort A will be a historical cohort, focusing on patients with major bleeding who were on FXa inhibitor treatment. The study will examine the period from admission for bleeding until hospital discharge. Cohort B will include patients who received reversal or replacement therapy for managing major bleeding while being treated with FXa inhibitors. The study will follow these patients for up to three months after the administration of reversal or replacement therapy.
The main goal of this study is to generate real-world evidence that describes patient characteristics and treatment patterns for patients experiencing major bleeding while on FXa inhibitors. By doing so, the study aims to improve adherence to guidelines and optimize patient care.
The study will primarily focus on the United States, Japan, Germany, and the United Kingdom, but data from other countries will also be considered to ensure a comprehensive analysis. This research will provide valuable insights into the management and outcomes of major bleeding events in patients receiving FXa inhibitor treatment, with the ultimate aim of enhancing patient care and adherence to best practices.
Summary of results
Study title: REVERXaL 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
Sponsor: AstraZeneca AB (Sweden)
Study type: Multinational, observational, longitudinal cohort (Phase IV)
Countries: Germany, Japan, United Kingdom (UK), United States (USA)
Timeline: First patient 04 Dec 2023; last patient 15 Nov 2024 Study Purpose: The study looked at people taking Factor Xa blood thinners (apixaban, rivaroxaban, and edoxaban in Japan) who had major bleeding. It examined which patients were affected, what treatments they received in hospital, and how they did afterward. Major bleeding means life-threatening or very serious bleeding, such as bleeding in a critical part of the body (like the brain), needing 2 or more units of blood, a large drop in haemoglobin (≥2 g/dL), or bleeding that leads to death.
Design: Data from two groups of patients were collected and analysed:
How the study was done
• Group A: Researchers reviewed hospital records from the past two years for patients who had major bleeding while taking these medicines.
• Group B: Researchers followed patients in real time if they received a reversal or replacement treatment (RRT) to help stop bleeding during emergency care.
• Public involvement:
• Three people who had previously experienced major bleeding while on these medicines reviewed the patient information sheet. Their feedback led to clearer explanations about why personal data are collected, how patients would be updated about the study, and simpler wording.
Participants:
• Group A: 2025 patients were included. Most were older than 65 years. The most common type of bleed was intracerebral haemorrhage (bleeding in the brain). About 70% received treatments to reverse or replace the blood thinner’s effect (often andexanet alfa or prothrombin complex concentrates). Bleeding was controlled in 74% and 22% died before leaving the hospital, most due to the bleeding itself. The timing and type of treatment differed by country and by bleeding type.
• Group B: enrolled 131 patients before early closure due to slow enrolment. Most received andexanet alfa or prothrombin complex concentrates. Bleeding was controlled in 88%. One serious side effect (a pulmonary embolism, a blood clot in the lungs) was judged related to andexanet alfa.
Key study observations:
• Treatment approaches varied by country, by the type of bleeding, and by the blood thinner used. In Japan (Group A), hospitals gave reversal treatments sooner. Blood transfusions were used more often for gastrointestinal (stomach or bowel) bleeding. Restarting blood thinners at discharge differed by region and was most common in Japan
Conclusion:
• Major bleeding while on Factor Xa blood thinners is complex and often requires significant hospital resources. Real-world care varies widely, and outcomes—especially for brain bleeds—can be very serious. The study highlights the need for more standardised treatment approaches to improve patient care.
Please note: This is a summary of the main results from this study overall. The individual results of each participant might be different and are not in this summary.REC name
London - Bromley Research Ethics Committee
REC reference
24/PR/0297
Date of REC Opinion
25 Apr 2024
REC opinion
Further Information Favourable Opinion