Rotational thromboelastometry‐guided blood component use in cirrhotic children undergoing invasive procedures: Randomized controlled trial

Abstract

Background & Aims: This randomized controlled trial (RCT) was conducted with the aim to evaluate the efficacy and safety of using ROTEM-based transfusion strategy in cirrhotic children undergoing invasive procedures. Methods:This was an open-label, RCT which included (i) children under 18 years of age with liver cirrhosis; (ii) INR between 1.5 and 2.5; and/or (iii) platelet count between 20 × 10 9 /L and 50 × 10 9 /L (for procedures other than liver biopsy) and between 40 × 10 9 /L and 60 × 10 9 /L (for liver biopsy); and (iv) listed for invasive procedures.Stratified randomization was done for children undergoing liver biopsies. Patients randomized to the ROTEM and conventional groups received blood component transfusion using predefined criteria.Results: A total of 423 invasive procedures were screened for inclusion of which 60 were randomized (30 in each group with comparable baseline parameters). The volume of total blood components, fresh frozen plasma (FFP) and platelets transfused was significantly lower in ROTEM as compared to conventional group. Only 46.7% of children in ROTEM group received a blood component compared to 100% in conventional group (p < .001).The requirement of FFP (ROTEM: 43.3%, Conventional: 83.3%, p = .001) was significantly lower in the patients receiving ROTEM-guided transfusions. There was no difference in procedure-related bleed and transfusion-related complications between the two groups.ROTEM was cost-effective (p = .002) despite the additional cost of the test. Conclusion: ROTEM-based transfusion strategies result in lower blood component transfusion in cirrhotic children undergoing invasive procedures without an increase in risk of procedure-related bleed. ROTEM-guided transfusion strategy is cost-effective. K E Y W O R D S cost-effectiveness, invasive procedures in cirrhotic children, liver biopsy, rotational thromoelastometry, ROTEM-guided blood component transfusion, viscoelastic tests in cirrhotic children | 2493 MARIA et al.

Treating periprocedural bleeding in patients with cirrhosis

“…Employing a VET-guided approach to preprocedural bleeding risk assessments could, therefore, focus usage of blood products and factor concentrates on only patients with the highest risk of bleeding, thus avoiding an unnecessary and risky procedure in patients that may not need it, and improving both overall resource utilization and cost-effectiveness. This has further been demonstrated in a randomized controlled trial of children with cirrhosis who underwent invasive procedures, in which rotational thromboelastometry (ROTEM)-based transfusion strategies reduced the requirement for blood component transfusion and was found to be cost-effective ( p = 0.002) [ 8 ].…”

Viscoelastic testing: Critical appraisal of new methodologies and current literature

“…79 Use of screening pre-procedure VET (rather than CCT) in patients with liver failure has been shown to reduce transfusions without increased risk of bleeding. 79,80 Liver transplantation presents unique coagulation and transfusion challenges due to the dramatic changes seen during different phases of the operation. During the pre-explant phase, the hemostatic aberrations previously described in liver failure are present.…”

“…Cirrhotic patients with prolonged PT/INR and thrombocytopenia frequently show no significant functional evidence of coagulopathy on VET analysis 79 . Use of screening pre‐procedure VET (rather than CCT) in patients with liver failure has been shown to reduce transfusions without increased risk of bleeding 79,80 …”

A combination of clot formation abnormalities in thromboelastometry has a high prognostic value in patients with acute-on-chronic liver failure

“…More specifically, ROTEM assesses the strength and time properties of clot formation in non-centrifuged, citrated, whole blood. ROTEM was used as a reliable guide to hemostatic management of major surgical procedures in patients with liver cirrhosis, especially liver transplantation [9,10] or other invasive procedures [11]. However, limited data exist regarding the clinical relevance of ROTEM in acute-on-chronic liver failure (ACLF) [12][13][14][15][16], a syndrome characterized by extrahepatic multi-organ failures and high mortality [17], often requiring intensive care, red blood cells (RBCs) and blood products transfusions or probably coagulation factor concentrate administration [18,19].…”