Rotational Thromboelastometry (ROTEM) reduces the need for pre-emptive transfusion in cirrhosis: A randomized controlled Trial (NCT:05698134).

Abstract Backgrounds and Aim: Viscoelastic tests (VET) like Rotational Thromboelastometry (ROTEM) assess global hemostasis in cirrhosis. We aimed to assess whether ROTEM-guided blood product transfusion results in lower blood product requirement in patients with cirrhosis undergoing elective invasive procedures as compared to standard of care (SOC) based on conventional coagulation test (CCT).Methods In this open label randomized controlled trial, patients with cirrhosis and abnormal CCT who were undergoing an invasive procedure were randomized to receive blood products either by ROTEM-guidance or SOC. The primary outcome was the difference in blood products (fresh frozen plasma (FFP) or platelets) transfused between the group. The secondary outcome was procedure-related bleeding or complications within 7 days of the procedure. The trial protocol is registered at clinicaltrails.gov; NCT05698134.Results From August 2021 to January 2023, a total of 40 patients were recruited (ROTEM: (n = 20) and SOC (n = 20)). The trial was terminated earlier during interim analyses due to compelling benefit in the ROTEM group after a scheduled interim analysis. The ROTEM group required substantially less blood transfusion than the SOC group (40% [8/20] vs 100% [20/20], p < 0.001). The benefit was consistent across all types of blood product including fresh frozen plasma (< 0.001) and pooled platelet (p = 0.046). No patients experienced clinically significant bleeding events. Transfusion associated adverse events occurred in one patient (5%) in the SOC group (allergic reaction) and none in ROTEM group (p = NS). The mortality in both groups at 30 and 90 days were similar.Conclusions Viscoelastic tests like ROTEM provides global assessment of hemostasis in patients with cirrhosis. Institution of ROTEM based transfusion strategy significantly reduces the need for blood product transfusion in patients with cirrhosis undergoing elective procedure without any increased risk of bleeding events.