Presentation Details
| A Comparison of Targeted High-Range versus Low-Range Anti-Xa Goal for Intravenous Unfractionated Heparin in Patients with Mechanical Circulatory Support Devices Yue Wang, Long To, Mathew Jones, Kristin Griebe. Henry Ford Hospital, Detroit, MI, USA |
Abstract
Background: Patients presenting with cardiogenic shock are commonly supported by mechanical circulatory support (MCS) devices. Although MCS may restore organ perfusion, complications from the biomaterials and shear forces created by the devices can increase the risks of bleeding and thrombosis. Intravenous (IV) unfractionated heparin is currently the most commonly used anticoagulation therapy with MCS. Although current literature does not define optimal therapeutic targets when monitoring heparin in this setting, the most commonly accepted therapeutic range for anti-Xa is 0.3 to 0.7 units/mL. When patients are treated with IV heparin while on MCS devices, the bleeding risk increases. There have been bleeding events reported at different observed anti-Xa levels ranging from 0.1 to 0.7 units/mL in previous studies. At Henry Ford Hospital, the anti-Xa goal was decreased from a high range of 0.3 to 0.7 units/mL to a low range of 0.2 to 0.5 units/mL with the hypothesis that a lower range of targeted anti-Xa goal may decrease the incidence of bleeding while maintaining adequate antithrombotic effects. This study aims to evaluate if the targeted low-range anti-Xa goal decreases the incidence of bleeding compared to the high-range anti-Xa goal when patients receive IV heparin with MCS devices. Objectives: The primary endpoint is to compare the incidence of bleeding when using the targeted low-range versus high-range anti-Xa goal. The secondary endpoints are to compare the incidence of thrombosis using the low-range versus high-range goal and to describe clinical scenarios of protocol deviation. Independent confounding risk factors of developing bleeding and thrombotic complications will be assessed. ICU length of stay and mortality attributed to bleeding, thrombosis, and cohort overall will be reported. Methods: This is a retrospective, single-center, quasi-experimental study to evaluate adult patients (older than 18 years old) on IV heparin for MCS devices with at least one anti-Xa collected during their hospital admission to the cardiovascular intensive care unit. The pre-cohort contains patients monitored in the high-range anti-Xa goal and the post-cohort contains patients monitored in the low-range anti-Xa goal. A planned subgroup analysis will be conducted on patients whose therapeutic ranges were changed during the course of therapy. Bivariate analysis will be used to compare the percentages of patients with each outcome according to exposure within the cohort. Multivariate logistic regression will be used to evaluate confounding factors. Kaplan-Meier curves will be used to describe time to event (bleeding, thrombosis, mortality attributed to bleeding or thrombosis). 304 patients are required for 80% power to detect a 15% reduction in major bleeding with an alpha of 0.05. Results: in progress Conclusion: in progress
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