REVERXaL Study
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
335317
Contact name
Raza Alikhan
Contact email
Sponsor organisation
AstraZeneca
Duration of Study in the UK
1 years, 2 months, 6 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.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
23/PR/1327
Date of REC Opinion
21 Dec 2023
REC opinion
Unfavourable Opinion