Quantra® supported hemotherapy algorithm in cardiac surgery: Protocol for a prospective randomized controlled monocentric trial (Preprint) [post]

Sophie Michel, Florian Piekarski, Jan-Hendrik Fischer, Vanessa Hettler, Elisabeth Hannah Adam, Lars Holzer, Gösta Lotz, Thomas Walther, Kai Zacharowski, Florian Jürgen Raimann
2019 unpublished
BACKGROUND Point of care devices for performing targeted coagulation substitution in bleeding patients have become increasingly important in recent years. New on the market is the Quantra® from HemoSonics (LC, Charlottesville, VA, US). It uses sonorheometry, a sonic estimation of elasticity via resonance (SEER), a novel ultrasound-based technology that measures viscoelastic properties of whole blood. Several studies have already shown the comparability with devices already established on the
more » ... ket such as the ROTEM® (TEM International GmbH, Munich, Germany). OBJECTIVE In contrast to existing studies, the planned study will be the first prospective interventional study using the new Quantra® system in a cardiac surgical patient cohort. The aim is to investigate the non-inferiority between an already existing coagulation algorithm, based on ROTEM®/Multiplate®, and a new algorithm based on the Quantra®, for the treatment of coagulopathic cardiac surgical patients. METHODS The study is divided into two phases. In an initial observation phase, whole blood samples of 20 patients will be analyzed using both ROTEM®/Multiplate® and Quantra® obtained at three defined points of time (prior to surgery, after completion of cardiopulmonary bypass, on arrival in the intensive care unit). The obtained threshold values will be used to create an algorithm for hemotherapy. In a second intervention phase, the new algorithm will be tested against an algorithm used routineously for years at our department for non-inferiority. RESULTS The main objective of the examination is the cumulative loss of blood within 24 hours after surgery. Statistical calculations based on literature and in-house data suggest that the new algorithm is not inferior if the difference in cumulative blood loss is < 150ml/24 h. CONCLUSIONS Because of the comparability of the Quantra® sonorheometry system with ROTEM® rotational thromboelastometric measurement methods, the existing hemotherapy treatment algorithm can be adapted to the Quantra device with a proof of non-inferiority. CLINICALTRIAL International Registered Report Identifier (IRRID): clinicaltrials.gov: NCT03902275
doi:10.2196/preprints.17206 fatcat:6nkva4qaxfarnpnxctlmgjnivu