A Cohort, Semi-Randomized, open label quality improvement patient blood management (PBM) comparison of point of care viscoelastic coagulation monitors in cardiac surgery.

Abstract

Viscoelastic testing (VET), recommended for heart surgery, lacks adoption due to data reporting times (central laboratory coagulation assay-CLCA and laboratory VET tests) and interpretation (predicate VET devices). Three point of care (POC) -VET devices have now become available. The hypotheses of this quality initiative (QI), patient blood management program-PBM), was that: (1) Clinicians desire timely, easily interpreted coagulation data (2) Comparison of two (first available) POC-VETs would determine the technology embraced for PBM. To evaluate these hypotheses clinicians were surveyed as to need ease of use, acceptability, and support of the expanding PBM program before and after testing in operating rooms (ORs). This was not a randomized study to examine reduction in transfusion utilization or improved outcome. It was, however, a QI study to examine perception of an existing problem; with investigation of a solution the clinicians would support decision making. Cardiac team members (anesthesia, surgery, and perfusion) were informed, and their written consent was obtained prior to survey. Team members completed QI surveys before and after the use of the technologies. Anesthesiology members were trained by the manufacturers and assessed for proficiency by Laboratory Medicine (LM). The TEG-6s® and the Quantra® QPlus, evaluated in sixty-eight cardiac patients over a six-week period (May 15-June 30, 2021) gave the clinicians direct experience. The time from blood draw (arterial line) until final coagulation data reported were compared between technologies and where available to CLCA/lab testing. Algorithms for coagulation treatments with the POC-VET data were created in consultation with the manufacturers. QI survey data were reported as percentage of answers in categories. Time to data acquisition and blood usage (pilot data only) were examined with chi-square and Wilcoxon rank sum, two sided tests. Cardiac team members (anesthesia, surgery, and perfusion) were informed, and their written consent was obtained prior to survey. Team members completed QI surveys before and after the use of the technologies. Anesthesiology members were trained by the manufacturers and assessed for proficiency by Laboratory Medicine (LM). The TEG-6s® and the Quantra® QPlus, evaluated in sixty-eight cardiac patients over a six-week period (May 15 -June 30, 2021) gave the clinicians direct experience. The time from blood draw (arterial line) until final coagulation data reported were compared between technologies and where available to CLCA/lab testing. Algorithms for coagulation treatments with the POC-VET data were created in consultation with the manufacturers. QI survey data were reported as percentage of answers in categories. Time to data acquisition and blood usage (pilot data only) were examined with chi-square and Wilcoxon rank sum, two sided tests.