Coagulation Management of Critically Bleeding Patients With Viscoelastic Testing Presented as a 3D-Animated Blood Clot (The Visual Clot): Randomized Controlled High-Fidelity Simulation Study

Abstract

Background Guidelines recommend using viscoelastic coagulation tests to guide coagulation management, but interpreting the results remains challenging. Visual Clot, a 3D animated blood clot, facilitates interpretation through a user-centered and situation awareness–oriented design. Objective This study aims to compare the effects of Visual Clot versus conventional viscoelastic test results (rotational thrombelastometry [ROTEM] temograms) on the coagulation management performance of anesthesia teams in critical bleeding situations. Methods We conducted a prospective, randomized, high-fidelity simulation study in which anesthesia teams (consisting of a senior anesthesiologist, a resident anesthesiologist, and an anesthesia nurse) managed perioperative bleeding scenarios. Teams had either Visual Clot or ROTEM temograms available to perform targeted coagulation management. We analyzed the 15-minute simulations with post hoc video analysis. The primary outcome was correct targeted coagulation therapy. Secondary outcomes were time to targeted coagulation therapy, confidence, and workload. In addition, we have conducted a qualitative survey on user acceptance of Visual Clot. We used Poisson regression, Cox regression, and mixed logistic regression models, adjusted for various potential confounders, to analyze the data. Results We analyzed 59 simulations. Teams using Visual Clot were more likely to deliver the overall targeted coagulation therapy correctly (rate ratio 1.56, 95% CI 1.00-2.47; P=.05) and administer the first targeted coagulation product faster (hazard ratio 2.58, 95% CI 1.37-4.85; P=.003). In addition, participants showed higher decision confidence with Visual Clot (odds ratio 3.60, 95% CI 1.49-8.71; P=.005). We found no difference in workload (coefficient –0.03, 95% CI –3.08 to 2.88; P=.99). Conclusions Using Visual Clot led to a more accurate and faster-targeted coagulation therapy than using ROTEM temograms. We suggest that relevant viscoelastic test manufacturers consider augmenting their complex result presentation with intuitive, easy-to-understand visualization to ease users’ burden from unnecessary cognitive load and enhance patient care.

User Perceptions of Visual Clot in a High-Fidelity Simulation Study: Mixed Qualitative-Quantitative Study

“…Anesthesia providers using Visual Clot in a high-fidelity simulation study were more likely to correctly administer targeted coagulation therapy and to give the first targeted coagulation product faster. In addition, participants demonstrated greater decision-making confidence with Visual Clot [23]. Moreover, the correctness of the clinical decisions was independent of previous rotational thromboelastometry knowledge and experience.…”

“…In the high-fidelity simulation study [23], anesthesia teams, composed of a staff anesthesiologist, a resident, and an anesthesia nurse, participated in high-fidelity perioperative bleeding scenarios using either Visual Clot or ROTEM. The primary outcome of the study was correct targeted coagulation therapy.…”

“…Previous Visual Clot studies [22][23][24]36,37] underline the benefits of additional visualization technology, simplifying standard ROTEM data interpretation [20]. Anesthesia providers using Visual Clot in a high-fidelity simulation study were more likely to correctly administer targeted coagulation therapy and to give the first targeted coagulation product faster.…”

“…Overall, physicians presented with the results of viscoelastic testing using Visual Clot were approximately 56% more likely to provide accurate therapeutic interventions. In the same study, physicians were 3.5 times more likely to feel confident in their decisions when working with Visual Clot compared to traditional ROTEM results [23]. In the first computer-based study analyzing user perceptions of Visual Clot, participants described the technology as well-designed, easy to learn, and intuitive [24].…”