Michel Sophie, Piekarski Florian, Fischer Jan-Hendrik, Hettler Vanessa, Adam Elisabeth Hannah, Holzer Lars, Lotz Gösta, Walther Thomas, Zacharowski Kai, Raimann Florian Jürgen
Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University, Frankfurt am Main, Germany.
JMIR Res Protoc. 2020 Apr 21;9(4):e17206. doi: 10.2196/17206.
Point 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.
In 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.
The 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.
The 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.
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.
ClinicalTrials.gov NCT03902275; https://clinicaltrials.gov/ct2/show/NCT03902275.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17206.
近年来，用于对出血患者进行靶向凝血替代的床旁设备变得越来越重要。市场上的新品是Quantra。它是一种采用声流变学技术的设备，通过共振对弹性进行声学估计，这是一种基于超声的新技术，可测量全血的粘弹性特性。多项研究已经表明Quantra与市场上已有的设备具有可比性，如旋转血栓弹力图（ROTEM）设备。
与现有研究不同，本研究是第一项在心脏手术患者队列中使用这种新系统的前瞻性干预性研究。我们将研究基于ROTEM/多电极血小板功能分析仪（Multiplate）系统的现有凝血算法与基于Quantra系统的新算法在治疗凝血病心脏手术患者方面的非劣效性。
本研究分为两个阶段。在初始观察阶段，将使用ROTEM/多电极血小板功能分析仪（Multiplate）系统和Quantra系统对20例患者在三个确定时间点（手术前、体外循环完成后以及重症监护病房入院时）采集的全血样本进行分析。获得的阈值将用于开发一种新的血液治疗算法。在第二个干预阶段，将对新算法与我们科室多年来常规使用的算法进行非劣效性测试。
检查的主要目标是术后24小时内的累计失血量。基于文献和内部数据的统计计算表明，如果累计失血量差异<150 mL/24小时，则新算法不劣于现有算法。
由于Quantra声流变学系统与ROTEM测量方法具有可比性，现有的血液治疗算法可以在证明非劣效性的情况下适用于Quantra设备。
ClinicalTrials.gov NCT03902275；https://clinicaltrials.gov/ct2/show/NCT03902275。
国际注册报告识别码（IRRID）：DERR1-10.2196/17206。
