Rotational Thromboelastometry Reduces the Need for Preemptive Transfusion in Cirrhosis: A Randomized Controlled Trial (NCT:05698134).

Autor: Kumar R; Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore.; DUKE-NUS Academic Medical Centre, Singapore., Ng LXL; Department of Anesthesia and Critical Care, Changi General Hospital, Singapore., Wong YJ; Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore.; DUKE-NUS Academic Medical Centre, Singapore., Tan CK; Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore., Wang LZ; Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore., Qiu TY; Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore., Wong B; Clinical Trials and Research Unit, Changi General Hospital Singapore., Lin KW; Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore., Li JW; Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore., Kwek ABE; Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore., Ang TL; Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore., Gokhle RS; Department of Respiratory Medicine and Critical Care, Changi General Hospital, Singapore., Sivanath TP; Department of Interventional Radiology, Changi General Hospital, Singapore.
Jazyk: angličtina
Zdroj: Journal of clinical and experimental hepatology [J Clin Exp Hepatol] 2025 Jan-Feb; Vol. 15 (1), pp. 102409. Date of Electronic Publication: 2024 Sep 07.
DOI: 10.1016/j.jceh.2024.102409
Abstrakt: Backgrounds and Aim: Viscoelastic tests (VET) like rotational thromboelastometry (ROTEM) assess global hemostasis in cirrhosis. We aimed to assess whether ROTEM-guided blood product transfusion results in lower blood product requirements in patients with cirrhosis undergoing elective invasive procedures as compared to standard of care (SOC) based on conventional coagulation test (CCT).
Methods: In this open label randomized controlled trial, patients with cirrhosis and abnormal CCT who were undergoing an invasive procedure were randomized to receive blood products either by ROTEM-guidance or SOC. The primary outcome was the difference in blood products (fresh frozen plasma (FFP) or platelets) transfused between the groups. The secondary outcome was procedure-related bleeding or complications within 7 days of the procedure. The trial protocol is registered at clinicaltrails.gov; NCT05698134.
Results: From August 2021 to January 2023, a total of 40 patients were recruited (ROTEM (n = 20) and SOC (n = 20)). The trial was terminated earlier during interim analyses due to compelling benefit in the ROTEM group after a scheduled interim analysis. The ROTEM group required substantially less blood transfusion than the SOC group (40% [8/20] vs 100% [20/20], P  < 0.001). The benefit was consistent across all types of blood product, including fresh frozen plasma (<0.001) and pooled platelets ( P  = 0.046). No patients experienced clinically significant bleeding events. Transfusion-associated adverse events occurred in one patient (5%) in the SOC group (allergic reaction) and none in the ROTEM group ( P  = NS). The mortality in both groups at 30 and 90 days was similar.
Conclusions: Viscoelastic tests like ROTEM provide global assessment of hemostasis in patients with cirrhosis. Institution of ROTEM based transfusion strategy significantly reduces the need for blood product transfusion in patients with cirrhosis undergoing elective procedure without any increased risk of bleeding events.
Clinical Trial Number: NCT05698134.
Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Rahul Kumar reports financial support was provided by Changi General Hospital. Rahul Kumar reports a relationship with Gilead Sciences Inc that includes: speaking and lecture fees and travel reimbursement. Rahul Kumar reports a relationship with AbbVie Inc that includes: speaking and lecture fees and travel reimbursement. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(© 2024 Indian National Association for Study of the Liver. Published by Elsevier B.V. All rights are reserved, including those for text and data mining, AI training, and similar technologies.)
Databáze: MEDLINE
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