Prediction of bleeding and thrombosis in patients on chronic hemodialysis with the total thrombus-formation analysis system

Abstract Background End-stage renal disease patients receiving hemodialysis (HD) are at increased risk of both bleeding and thrombotic complications. There are, however, few tools to help clinicians with risk stratification of the individual patient. Aims and Method To study if the Total Thrombus-formation Analysis System (T-TAS01), which measures thrombus formation in flowing whole blood inside a microchip [1], can be used to predict bleeding and thrombotic complications in patients on HD. Odds-ratios were calculated using the median split procedure. ROC curve analyses were performed to calculate the ability of T-TAS measurements performed at baseline to distinguish between patients with and without future bleeding or thrombotic complications. Results 176 patients on chronic HD were included and followed for one year; 11.4% were on antiplatelet drugs and 8.0% on continuous anticoagulation. Venous blood samples were taken at inclusion before dialysis procedure, and platelet-thrombus formation (PL-AUC; higher value reflects increased thrombogenicity) and platelet-fibrin thrombus formation (AR-OT; higher value reflects reduced thrombogenicity) were registered. Fifty-seven patients (32%) developed a bleeding complication, whereof 12 (6.8%) were ISTH major bleedings. The Odds-Ratio (OR; 95% CI) to develop any bleeding for patients with T-TAS01 measurements below (PL-AUC) or above (AR-OT) median were 7.67 (3.59-16.36) and 8.94 (4.10-19.51), respectively. ROC analyses to predict bleeding with T-TAS01 showed AUCs of 0.85 for all bleeding and 0.83 for ISTH major bleed (PL-AUC and AR-OT data combined). Furthermore, thirty-one patients (17.6%) developed a thrombotic complication, whereof 13 (7.4%) were acute coronary syndrome (ACS) or ischemic stroke (IS). The Odds-Ratio (OR; 95% CI) to develop any thrombosis for patients with T-TAS01 measurements below (PL-AUC) or above (AR-OT) median were 0.14 (0.05-0.40) and 0.28 (0.12-0.67), respectively. ROC analyses to predict thrombosis with T-TAS01 showed AUCs of 0.78 for all thrombosis and 0.62 for ACS/IS (PL-AUC and AR-OT data combined). Conclusion T-TAS01 is a promising tool to aid in the prediction of bleeding and thrombosis in HD patients.