TY  - JOUR
A1  - Michel, Sophie
A1  - Piekarski, Florian
A1  - Fischer, Jan-Hendrik
A1  - Hettler, Vanessa
A1  - Adam, Elisabeth
A1  - Holzer, Lars
A1  - Lotz, Gösta
A1  - Walther, Thomas
A1  - Zacharowski, Kai
A1  - Raimann, Florian
T1  - Hemostatis analyzer-supported hemotherapy algorithm in cardiac surgery: protocol for a randomized controlled monocentric trial
T2  - JMIR Research Protocols
N2  - Background: 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.
Objective: 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.
Methods: 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.
Results: 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.
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
KW  - Quantra
KW  - cardiothoracic surgery
KW  - bypass
KW  - coagulopathy
KW  - point of care
KW  - algorithm
KW  - rotational thromboelastometry
KW  - Multiplate
Y1  - 2020
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/55259
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-552592
SN  - 1929-0748
N1  - This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.
VL  - 9
IS  - 4, art e17206
PB  - JMIR Publications
CY  - Toronto
ER  -