Phase II Study to Evaluate Prolonged Anticoagulation with Apixaban for Preventing Blood Clots in Adults with Autoimmune Hemolytic Anemia

What this Trial Is About

Autoimmune hemolytic anemia AIHA is a rare autoimmune disease where the bodys immune system destroys red blood cells, leading to anemia and a high risk of venous thromboembolism VTE, especially within the first three months after diagnosis or relapse. The risk of VTE in AIHA patients is significantly higher than in the general population, but no clear clinical predictors have been identified. This study is a prospective, phase II, randomized, multicenter trial aiming to evaluate whether prolonged anticoagulation can reduce VTE occurrence in AIHA patients during this high-risk period. Participants will be randomly assigned to one of two groups. The intervention group will receive prophylactic heparin therapy during hospitalization followed by 12 weeks of oral anticoagulation with apixaban. The standard group will receive prophylactic heparin only during hospitalization, with no further preventive anticoagulation after discharge. Biological assessments including blood counts and markers related to hemolysis will be conducted. During the study, participants will be monitored for clinical venous thromboembolic events such as deep vein thrombosis and pulmonary embolism up to 24 weeks after randomization. Blood tests including complete blood count, reticulocytes, haptoglobin, LDH, and bilirubin will be collected. The trial involves follow-up visits to evaluate outcomes and ensure participant safety, with total involvement lasting several months to assess the effectiveness of prolonged anticoagulation in preventing VTE.

Efficacy of Prolonged Anticoagulation for Primary Prevention of Venous Thromboembolic Disease in Autoimmune Hemolytic Anemia: a Prospective, Phase II, Randomized, Multicenter Study