Abstract
BackgroundPoint of care devices for performing targeted coagulation substitution in patients who are bleeding have become increasingly important in recent years. New on the market is the Quantra. It is a device that uses sonorheometry, a sonic estimation of elasticity via resonance, which is a novel ultrasound-based technology that measures viscoelastic properties of whole blood. Several studies have already shown the comparability of the Quantra with devices already established on the market, such as the rotational thromboelastometry (ROTEM) device.ObjectiveIn contrast to existing studies, this study is the first prospective interventional study using this new system in a cardiac surgical patient cohort. We will investigate the noninferiority between an already existing coagulation algorithm based on the ROTEM/Multiplate system and a new algorithm based on the Quantra system for the treatment of coagulopathic cardiac surgical patients.MethodsThe study is divided into two phases. In an initial observation phase, whole blood samples of 20 patients obtained at three defined time points (prior to surgery, after completion of cardiopulmonary bypass, and on arrival in the intensive care unit) will be analyzed using both the ROTEM/Multiplate and Quantra systems. The obtained threshold values will be used to develop a novel algorithm for hemotherapy. In a second intervention phase, the new algorithm will be tested for noninferiority against an algorithm used routinely for years in our department.ResultsThe main objective of the examination is the cumulative loss of blood within 24 hours after surgery. Statistical calculations based on the literature and in-house data suggest that the new algorithm is not inferior if the difference in cumulative blood loss is <150 mL/24 hours.ConclusionsBecause of the comparability of the Quantra sonorheometry system with the ROTEM measurement methods, the existing hemotherapy treatment algorithm can be adapted to the Quantra device with proof of noninferiority.Trial RegistrationClinicalTrials.gov NCT03902275; https://clinicaltrials.gov/ct2/show/NCT03902275International Registered Report Identifier (IRRID)DERR1-10.2196/17206
Highlights
BackgroundA targeted coagulation therapy during intra- and postoperative care for cardiac surgical patients needs an accurate knowledge of their hemostatic conditions
An evaluation of the platelet activity for the Quantra device system in a cardiac surgical patient trial, [5] as well as the comparability procedures with rotational thromboelastometry (ROTEM) measures has already been assessed [5,6]. In this first interventional study, our main objective is to show the noninferiority of a new Quantra-based hemotherapy algorithm in comparison to an existing algorithm based on the ROTEM delta and Multiplate used in our clinical routine
We want to show the noninferiority of a Quantra-based hemotherapy algorithm compared to the ROTEM and Multiplate system
Summary
BackgroundA targeted coagulation therapy during intra- and postoperative care for cardiac surgical patients needs an accurate knowledge of their hemostatic conditions. Point-of-care testing (POCT) devices for the diagnosis of patients who are coagulopathic have become increasingly important. We will investigate the noninferiority between an already existing coagulation algorithm based on the ROTEM/Multiplate system and a new algorithm based on the Quantra system for the treatment of coagulopathic cardiac surgical patients. In an initial observation phase, whole blood samples of 20 patients obtained at three defined time points (prior to surgery, after completion of cardiopulmonary bypass, and on arrival in the intensive care unit) will be analyzed using both the ROTEM/Multiplate and Quantra systems. Conclusions: Because of the comparability of the Quantra sonorheometry system with the ROTEM measurement methods, the existing hemotherapy treatment algorithm can be adapted to the Quantra device with proof of noninferiority. Trial Registration: ClinicalTrials.gov NCT03902275; https://clinicaltrials.gov/ct2/show/NCT03902275 International Registered Report Identifier (IRRID): DERR1-10.2196/17206
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