RESUMEN
The Haemostasis Traffic Light is a cognitive aid with a user-centred design to enhance and simplify situation awareness and decision-making during peri-operative bleeding. Its structure helps to prioritise therapeutic interventions according to the pathophysiology and the severity of the bleeding. This investigator-initiated, randomised, prospective, international, dual-centre study aimed to validate the Haemostasis Traffic Light by adapting it to the local coagulation protocols of two university hospitals. Between 9 January and 12 May 2020, we recruited 84 participants at the University Hospital Zurich, Switzerland, and the Italian Hospital of Buenos Aires, Argentina. Each centre included 21 resident and 21 staff anaesthetists. Participants were randomly allocated to either the text-based algorithm or the Haemostasis Traffic Light. All participants managed six bleeding scenarios using the same algorithm. In simulated bleeding scenarios, the design of the Haemostasis Traffic Light algorithm enabled more correctly solved cases, OR (95%CI) 7.23 (3.82-13.68), p < 0.001, and faster therapeutic decisions, HR (95%CI) 1.97 (1.18-3.29, p = 0.010). In addition, the tool improved therapeutic confidence, OR (95%CI) 4.31 (1.67-11.11, p = 0.003), and reduced perceived work-load coefficient (95%CI) -6.1 (-10.98 to -1.22), p = 0.020). This study provides empirical evidence for the importance of user-centred design in the development of haemostatic management protocols.