{Reference Type}: Journal Article
{Title}: Design and rationale for REVERXaL: A real-world study of patients with factor Xa inhibitor-associated major bleeds.
{Author}: Alikhan R;Nour M;Yasaka M;Ofori-Asenso R;Axelsson-Chéramy S;Chen H;Seghal V;Yokobori S;Koch B;Tiede A;Cash BD;Maegele M;Singer AJ;
{Journal}: Thromb Res
{Volume}: 240
{Issue}: 0
{Year}: 2024 Jun 5
{Factor}: 10.407
{DOI}: 10.1016/j.thromres.2024.109046
{Abstract}: <B>BACKGROUND: </B>The prevalence of anticoagulation treatment is increasing as an aging global population faces a high burden of cardiovascular comorbidities. Direct oral anticoagulants, including factor Xa inhibitors (FXai), are replacing vitamin K antagonists as the most commonly prescribed treatment for reducing risk of thrombotic events. While the risk of FXai-associated spontaneous bleeds is established, less is understood about their management and the effect of treatment on clinical and patient-reported outcomes. The primary objectives of the REVERXaL study are to describe patient characteristics, health care interventions during the acute-care phase, in-hospital outcomes, and associations between timing of reversal/replacement agent administration and in-hospital outcomes. Secondary/exploratory objectives focus on clinical assessments and patient-reported outcome measures (PROMs) at 30 and 90 days.<BR><B>METHODS: </B>REVERXaL is a multinational, observational study of hospitalized patients with FXai-associated major bleeds in Germany, Japan, the United Kingdom, and the United States. The study includes 2 cohorts of approximately 2000 patients each. Cohort A is a historic cohort for whom medical chart data will be collected from hospitalization to discharge for patients admitted for major bleeds during FXai use within 2 years prior to enrollment of Cohort B. Cohort B will prospectively enroll patients administered any reversal/replacement agent during hospitalization to manage FXai-associated major bleeds and will include the collection of clinical outcomes and PROMs data over 3 months.<BR><B>CONCLUSIONS: </B>REVERXaL will generate insights on patient characteristics, treatment approaches, and associated outcomes in patients hospitalized with FXai-associated major bleeds. These data may inform clinical practice and streamline treatment pathways in this population.<BR><B>BACKGROUND: </B>URL: https://www.<BR><B>RESULTS: </B>gov; unique identifier: NCT06147830.