Baseline Thrombin Generation Test Does Not Predict Thrombotic Events in Acute Leukemia: A Monocentric Prospective Study

Thromboembolic and hemorrhagic complications are significant causes of morbidity and mortality in patients with acute leukemias (AL). While AL is characterized by a complex hemostatic imbalance, conventional coagulation tests and platelet counts offer limited predictive value for bleeding and thrombotic events. Global coagulation assays (GCAs), such as the Thrombin Generation Assay (TGA), provide a more comprehensive assessment of coagulation potential and may offer improved risk stratification. This prospective, single-center pilot study aimed to explore the utility of TGA in newly diagnosed adult patients with AL. Between February 2022 and September 2024, 111 patients were enrolled at the Department of Translational and Precision Medicine, Sapienza University of Rome. Baseline clinical and laboratory data, including TGA parameters, were collected, and patients were monitored for thrombotic events until death or last follow-up. TGA values at diagnosis displayed wide inter-individual and inter-subtype variability. With a median follow-up of 8.28 months, 8 (7.2%) thrombotic events were reported. No statistically significant association was found between baseline TGA parameters and the development of thrombotic events (p > 0.05). These findings suggest that a single TGA measurement at diagnosis may not predict thrombotic risk in AL patients. Future studies incorporating longitudinal TGA assessments and additional hemostatic evaluations, such as platelet function analysis, may help refine risk prediction for both thrombotic and hemorrhagic complications in this high-risk population.