ROTEM-guided blood product transfusion in patients with cirrhosis having invasive procedures: a randomized controlled trial.

BACKGROUND & AIMS: Peri-procedural blood component(s) prophylaxis is common in patients with cirrhosis undergoing invasive procedures. We evaluated whether a rotational thromboelastometry (ROTEM)-guided algorithm could reduce prophylactic transfusions without increasing bleeding complications. METHODS: In this randomized controlled trial, adults with cirrhosis scheduled for invasive procedures with abnormal INR and/or platelet count values requiring preprocedural correction as per standard local practice were randomized 1:1 to a ROTEM-guided or standard-of-care (SOC) transfusion strategy. The primary efficacy outcome was the proportion of procedures that required prophylactic transfusion of blood components(s). The primary safety outcome was major procedure-related bleeding. Secondary outcomes included type and volume of blood products transfused, transfusion reactions, thrombosis, and 28-day mortality. RESULTS: A total of 114 procedures in 99 patients were screened with 57 randomized (28 in ROTEM, 29 in SOC). 44 procedures (77%) were classified as having a high bleeding risk. Prophylactic blood products were administered before 20 procedures in the ROTEM group compared to 28 in the SOC group (71% vs. 97%, p<0.01). The pattern of blood product use differed between the groups, with less FFP and more cryoprecipitate in the ROTEM group than in the SOC group. There was no difference in procedure-related bleeding (no major bleeding was recorded), thrombosis, transfusion-related complications, length of stay, or mortality between the two groups. CONCLUSIONS: ROTEM-guided transfusion significantly reduced blood product use without compromising safety in cirrhosis patients undergoing invasive procedures. These findings support a more conservative, goal-directed approach to periprocedural hemostatic management in patients with cirrhosis.