Thrombelastometry-guided Blood Component Administration Versus Standard of Care in Patients With Decompensated Liver Cirrhosis Undergoing Invasive Procedures

Official title

Thrombelastometry-guided Blood Component Administration Versus Standard of Care in Patients With Decompensated Liver Cirrhosis Undergoing High Risk of Bleeding Invasive Procedures

Overview

Patients with liver cirrhosis have historically received prophylactic transfusions before invasive procedures with high risk of bleeding. The optimal method for establishing the need of blood transfusion before invasive procedures in cirrhotic patients has not been determined yet, and there are not enough scientific data to warrant empirical transfusion. In many surgical and trauma-related contexts, viscoelastic tests, like Rotational Thromboelastometry (ROTEM), offer a comprehensive assessment of hemostasis, and it has been demonstrated to predict bleeding risk more accurately than traditional coagulation tests. The aim of this project is to evaluate the efficacy of a ROTEM-based algorithm in managing the administration of prophylactic blood components to patients diagnosed with decompensated liver cirrhosis undergoing invasive high risk of bleeding procedures. The investigators hypothesized that ROTEM-based decision-making will lead to a reduction in pre-procedural blood component usage, particularly fresh frozen plasma (FFP), compared with standard of care, whilst maintaining optimal clinical outcomes. The investigators will perform a prospective, single-center, randomized controlled clinical trial in a tertiary university hospital in Romania, comparing ROTEM-guided prophylactic blood component administration to standard of care in patients with decompensated cirrhosis and coagulopathy undergoing invasive procedures. Inclusion criteria: adults (aged 18 years or older) admitted with cirrhosis and an indication for high risk of bleeding invasive procedure defined as: transjugular liver biopsy, transjugular intrahepatic portosystemic shunt, endoscopic retrograde cholangio-pancreatography with sphincterotomy, endoscopic polypectomy of polyps more than 1 cm, variceal banding and complex dental extraction. The primary safety endpoint will be the incidence of major bleeding. Secondary endpoints will be the proportion of blood products transfusion, hospital length of stay, in-hospital and 28-day mortality, incidence of minor bleeding, transfusion related adverse reactions, and cost analysis.

Detailed description

This project will compare two blood transfusion protocols (coagulogram-based and thromboelastometry-based) prior to high risk of bleeding procedures in patients with cirrhosis. The investigators hypothesized that thromboelastometry-guided transfusion protocols are safe and would decrease the need of blood products transfusion compared to an ordinary coagulogram-based protocol in patients with decompensated cirrhosis receiving high risk of bleeding procedures.

Interventions

• Procedure Blood Products transfusion
  Blood Products transfusion

Primary outcome measures

• The proportion of patients transfused with any blood product [Time frame: From the enrollment to 30 days after the procedure]
• The incidence of major bleeding within the first 24 h [Time frame: From the enrollment to 30 days after the procedure]

Secondary outcome measures (4)

• The incidence of acute transfusion-related adverse events [Time frame: From enrollment to 30 days after the procedure]
• The hospital length of stay [Time frame: From enrollment to 30 days after the procedure]
• In hospital mortality [Time frame: From the enrollment to discharge or death]
• 30-days mortality [Time frame: From date of randomization until the end of the study or the date of death from any cause, whichever came first, assessed up to 30 days.]

Eligibility criteria

Inclusion criteria

• diagnosed with decompensated liver cirrhosis of any etiology
• planned for a high risk of bleeding invasive procedure
• coagulopathic based on conventional coagulation tests and considered for pre-procedural blood component prophylaxis
• able and willing to provide informed consent

Exclusion criteria

• acute liver failure
• current use of anticoagulant treatment
• patients on antiplatelet aggregation agents
• patients who have received FFP, platelet transfusion, cryoprecipitate in the week prior to the procedure
• patients with stage 4 or 5 chronic kidney disease or patients receiving renal replacement therapy
• sepsis

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Romania · 1 center

• Institute of Gastroenterology and Hepatology — Iași

Publications

• Northup PG, Garcia-Pagan JC, Garcia-Tsao G, Intagliata NM, Superina RA, Roberts LN, Lisman T, Valla DC. Vascular Liver Disorders, Portal Vein Thrombosis, and Procedural Bleeding in Patients With Liver Disease: 2020 Practice Guidance by the American Association for the Study of Liver Diseases. Hepatology. 2021 Jan;73(1):366-413. doi: 10.1002/hep.31646. Epub 2021 Jan 20. No abstract available. PMID 33219529
• Riescher-Tuczkiewicz A, Caldwell SH, Kamath PS, Villa E, Rautou PE; Bleeding in liver diseases investigatorsdagger; Bleeding in liver diseases investigators. Expert opinion on bleeding risk from invasive procedures in cirrhosis. JHEP Rep. 2023 Dec 19;6(3):100986. doi: 10.1016/j.jhepr.2023.100986. eCollection 2024 Mar. PMID 38384669
• Tangcheewinsirikul N, Moonla C, Uaprasert N, Pittayanon R, Rojnuckarin P. Viscoelastometric versus standard coagulation tests to guide periprocedural transfusion in adults with cirrhosis: A meta-analysis of randomized controlled trials. Vox Sang. 2022 Apr;117(4):553-561. doi: 10.1111/vox.13225. Epub 2021 Dec 15. PMID 34911140
• Intagliata NM, Davitkov P, Allen AM, Falck-Ytter YT, Stine JG. AGA Technical Review on Coagulation in Cirrhosis. Gastroenterology. 2021 Nov;161(5):1630-1656. doi: 10.1053/j.gastro.2021.09.004. Epub 2021 Sep 25. No abstract available. PMID 34579937
• European Association for the Study of the Liver. EASL Clinical Practice Guidelines on prevention and management of bleeding and thrombosis in patients with cirrhosis. J Hepatol. 2022 May;76(5):1151-1184. doi: 10.1016/j.jhep.2021.09.003. Epub 2022 Mar 15. PMID 35300861

Identifiers

NCT: NCT07437755 · 13536

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗