Comparison of relaxed verses standard cut-offs of rotational thromboelastometry for guiding blood product use before invasive procedures in advanced cirrhosis: a randomized controlled trial.

Background: The cut-offs of viscoelastic hemostatic assays used for guiding blood products transfusion in patients with cirrhosis undergoing invasive procedures are arbitrary. The aim of this study was to evaluate the efficacy and safety of two different ROTEM thresholds ["relaxed" ROTEM thresholds vs. "conventional" thresholds used in liver transplantation] for prophylactic blood product transfusion for invasive procedures in advanced cirrhosis patients with impaired traditional coagulation.

Material and methods: Patients with advanced cirrhosis scheduled to undergo invasive procedures with high inherent procedure bleeding risk or low inherent procedure bleeding risk along with the presence of any adverse patient specific factors, and abnormalities on conventional coagulation tests requiring correction (any of the following: platelet count < 30 × 10⁹/L, INR > 2.0, and plasma fibrinogen < 100 mg/dL), were randomized to receive correction based on standard ROTEM criteria (n = 519, MELD = 26.5 ± 7.4, CTP score = 12.4 ± 2.3, intrinsic low-risk procedure with any high-risk patient factors = 72.2%, intrinsic high-risk procedure with/without high-risk patient factors = 27.8%) or relaxed ROTEM criteria (n = 524, MELD = 25.6 ± 8.0, CTP score = 12.2 ± 2.7, intrinsic low-risk procedure with any high-risk patient factors = 64.1%, intrinsic high-risk procedure with/without high-risk patient factors = 35.9%). Patients in the standard and relaxed criteria groups received blood components using the following triggers, respectively: Fresh frozen plasma (FFP, 10 ml/kg) when EXTEM-CT > 80 or > 90 s; one pooled of single donor platelet unit or 6 pooled units of random donor platelet when EXTEM-MCF/ FIBTEM-MCF < 35/ ≥ 8 mm or < 30/ ≥ 7 mm; and 5 pooled units of cryoprecipitate if EXTEM-MCF/ FIBTEM-MCF < 35 / < 8 mm or < 30/ < 7 mm. The primary outcome measure was the proportion of patients requiring any blood products transfusion (i.e., FFP /platelets /cryoprecipitate).

Results: The proportion of patients transfused any blood product (FFP, platelets or cryoprecipitate) was 287/524 (54.8%) in the relaxed ROTEM group versus 352/519 (67.8%) in the standard ROTEM group (p < 0.001). Procedure-related bleeding and non-bleeding complications and 28-day mortality were similar in both the groups.

Conclusions: Relaxation of ROTEM cut-offs leads to lower prophylactic blood products transfusions without increased risk of bleeding in patients with advanced cirrhosis undergoing invasive procedures.