Rotational thromboelastometry versus conventional tests in decompensated cirrhotic children undergoing invasive procedures.

OBJECTIVES

This randomized controlled trial (RCT) aimed to evaluate the efficacy and safety of a rotational thromboelastometry (ROTEM)-guided transfusion strategy in children with decompensated cirrhosis presenting with severe coagulopathy and/or thrombocytopenia undergoing invasive procedures.

METHODS

This was an open-label, RCT which included (i) children 6 months to 18 years of age with decompensated liver cirrhosis, (ii) international normalized ratio (INR) between 2.5 and 3.5 (for procedures other than liver biopsy) and 2-2.5 (for liver biopsy), and/or (iii) platelet count between 20 and 50 × 109/L listed for invasive procedures. An interactive web response system was used to randomize the patient. Blood component transfusions in both arms were administered according to a predefined criterion.

RESULTS

A total of 363 invasive procedures in decompensated chronic liver disease patients were screened for inclusion into the study. Of these, 76 were randomized (38 in each group with comparable baseline parameters). The proportion of patients receiving any blood component transfusion was significantly lower in the ROTEM arm (76.3% vs. 100%, p = 0.001). However, the volume of total and individual blood components transfused was comparable between groups. There was no difference in procedure-related bleed and transfusion-related complications between the two arms. In our study, the total costs incurred were higher in the ROTEM group (p < 0.001).

CONCLUSION

In this cohort of children with decompensated cirrhosis and severe coagulopathy, ROTEM-guided transfusion reduced overall transfusion exposure but did not decrease blood product volume and was not cost-effective under the applied thresholds.

TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05734001 (Clinicaltrials.gov); CTRI/2023/02/049779 (Clinical trials registry of India).