Rotational thromboelastometry versus conventional tests in decompensated cirrhotic children undergoing invasive
Snigdha Verma1, Bikrant Bihari Lal1, Rajeev Khanna1
1Department of Pediatric Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.
Insights
Rotational thromboelastometry (ROTEM)-guided transfusion in children with liver cirrhosis reduced transfusion exposure but did not lower blood product volume or costs. This strategy did not prove cost-effective for managing coagulopathy in pediatric patients.
Area of Science:
- Pediatric Hematology
- Hepatology
- Transfusion Medicine
Background:
- Children with decompensated cirrhosis often experience coagulopathy and thrombocytopenia.
- Invasive procedures in these patients necessitate careful management of bleeding risks.
- Rotational thromboelastometry (ROTEM) offers real-time assessment of hemostasis.
Purpose of the Study:
- To evaluate the efficacy and safety of a ROTEM-guided transfusion strategy.
- To compare ROTEM-guided transfusion with standard criteria in pediatric patients undergoing invasive procedures.
- To assess the impact on transfusion requirements, complications, and costs.
Main Methods:
- An open-label, randomized controlled trial (RCT) involving children aged 6 months to 18 years with decompensated liver cirrhosis.
- Patients with specific international normalized ratio (INR) or platelet count thresholds were randomized.
- Blood component transfusions were administered based on predefined criteria in both ROTEM-guided and standard care arms.
Main Results:
- A ROTEM-guided strategy significantly reduced the proportion of patients receiving any blood component transfusion (76.3% vs. 100%).
- However, the total volume of blood components transfused and the incidence of procedure-related bleeding or transfusion complications were comparable between groups.
- The ROTEM-guided approach resulted in higher total costs compared to standard care (p < 0.001).
Conclusions:
- ROTEM-guided transfusion in children with decompensated cirrhosis and coagulopathy decreases overall transfusion exposure.
- This strategy did not lead to a reduction in blood product volume transfused.
- The ROTEM-guided approach was not found to be cost-effective within the study's parameters.
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).
