TOPLINE

Rotational thromboelastometry (ROTEM)-guided transfusion reduced prophylactic blood product use among patients with cirrhosis undergoing invasive procedures, without increasing procedure-related bleeding, thrombosis, or mortality.

METHODOLOGY

• Patients with cirrhosis often show abnormal clotting-test results, but these tests do not actually help predict the risk for bleeding during procedures — most bleeding results from portal hypertension or physical trauma rather than true clotting failure. ROTEM measures how whole blood clots in real time, offering a more accurate picture that enables clinicians to safely avoid unnecessary transfusions.
• Researchers conducted a clinical trial at six Australian liver centers between February 2021 and December 2024, randomizing 57 procedures among patients with cirrhosis who were scheduled for an invasive procedure and had an abnormal international normalized ratio (INR) — a measure of blood clotting time — and/or platelet count.
• Patients received either ROTEM-guided transfusion (n = 28) or standard-of-care (SOC) transfusion (n = 29); the cohort had a median age of 56 years, and 42% of the patients were women; coagulation and ROTEM testing occurred within 24 hours before the procedure for inpatients and within 72 hours before the procedure for outpatients.
• Procedures posing a high risk for bleeding accounted for 77% of the interventions, including dental extractions (n = 13), liver biopsy (n = 10), transjugular intrahepatic portosystemic shunt (n = 4), and hepatocellular carcinoma locoregional therapies (n = 3).
• The primary efficacy outcome was the requirement for prophylactic blood product transfusion in relation to the procedure, and the primary safety outcome was major procedure-related bleeding, as defined by International Society on Thrombosis and Hemostasis criteria.

TAKEAWAY

• Prophylactic blood products were administered before 71% of the procedures in the ROTEM group vs 97% of the procedures in the SOC group (P < .01); 29% of the patients in the ROTEM group vs 3% of the patients in the SOC group received no blood products at all — an almost tenfold difference.
• Fresh frozen plasma use was significantly lower in the ROTEM group than in the SOC group (29% vs 66% of the procedures; P < .01), whereas cryoprecipitate use was higher in the ROTEM group than in the SOC group (36% vs 10%; P = .02); platelet transfusion rates were not significantly different between the groups.
• The median total transfusion volume was significantly lower in the ROTEM group than in the SOC group (325 mL vs 570 mL; P = .03).
• No major procedure-related bleeding occurred in either group; rates of minor bleeding, thrombosis, and mortality did not differ significantly between the groups.

IN PRACTICE

"These findings provide robust clinical evidence supporting a shift from empiric correction of conventional coagulation abnormalities toward a more physiological, goal-directed approach to hemostatic management in cirrhosis," the authors wrote.

SOURCE

The study was led by Natasha Janko, of the Eastern Health Clinical School, Monash University, Melbourne, Australia. It was published online in Clinical Gastroenterology and Hepatology.

LIMITATIONS

Although the prespecified sample size was achieved, the trial was not powered to detect differences in bleeding events or mortality. The INR and platelet thresholds used to guide transfusion in the SOC group were not protocol-mandated and varied across sites. The proportion of patients with acute decompensation or acute-on-chronic liver failure was not captured, limiting the interpretation of the findings.

DISCLOSURES

The study was supported by a National Blood Authority Research Grant. Werfen Pty Ltd provided ROTEM devices on loan for the duration of the study but had no role in study design, data collection, analysis, or manuscript preparation. The authors reported having no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.