Hemostatis Analyzer-Supported Hemotherapy Algorithm in Cardiac Surgery: Protocol for a Randomized Controlled Monocentric Trial.
Multiplate
Quantra
algorithm
bypass
cardiothoracic surgery
coagulopathy
point of care
rotational thromboelastometry
Journal
JMIR research protocols
ISSN: 1929-0748
Titre abrégé: JMIR Res Protoc
Pays: Canada
ID NLM: 101599504
Informations de publication
Date de publication:
21 Apr 2020
21 Apr 2020
Historique:
received:
29
11
2019
accepted:
07
01
2020
revised:
04
01
2020
entrez:
22
4
2020
pubmed:
22
4
2020
medline:
22
4
2020
Statut:
epublish
Résumé
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. DERR1-10.2196/17206.
Sections du résumé
BACKGROUND
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
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
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
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
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
BACKGROUND
ClinicalTrials.gov NCT03902275; https://clinicaltrials.gov/ct2/show/NCT03902275.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
UNASSIGNED
DERR1-10.2196/17206.
Identifiants
pubmed: 32314972
pii: v9i4e17206
doi: 10.2196/17206
pmc: PMC7201313
doi:
Banques de données
ClinicalTrials.gov
['NCT03902275']
Types de publication
Journal Article
Langues
eng
Pagination
e17206Informations de copyright
©Sophie Michel, Florian Piekarski, Jan-Hendrik Fischer, Vanessa Hettler, Elisabeth Hannah Adam, Lars Holzer, Gösta Lotz, Thomas Walther, Kai Zacharowski, Florian Jürgen Raimann. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 21.04.2020.
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