旋转血栓弹性测定可降低肝硬化患者的预防性输血需求：随机对照试验 (NCT:05698134)

IF 3.3 Q2 GASTROENTEROLOGY & HEPATOLOGY

Journal of Clinical and Experimental Hepatology Pub Date : 2024-09-07 DOI:10.1016/j.jceh.2024.102409

Rahul Kumar , Louis X.L. Ng , Yu J. Wong , Chin K. Tan , Louis Z. Wang , Tian Y. Qiu , Benny Wong , Kenneth W. Lin , James W. Li , Andrew B.E. Kwek , Tiing L. Ang , Roshni S. Gokhle , Tirukonda P. Sivanath

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引用次数: 0

摘要

背景和目的血栓弹力检测（VET），如旋转血栓弹力仪（ROTEM）可评估肝硬化患者的整体止血情况。我们旨在评估与基于传统凝血试验（CCT）的标准护理（SOC）相比，ROTEM 指导下的血制品输注是否能降低接受择期侵入性手术的肝硬化患者对血制品的需求。在这项开放标签随机对照试验中，接受侵入性手术且 CCT 异常的肝硬化患者被随机分配接受 ROTEM 指导下的血制品或 SOC 指导下的血制品。主要结果是两组患者输注血液制品（新鲜冰冻血浆或血小板）的差异。次要结果是手术后 7 天内与手术相关的出血或并发症。试验方案注册于 clinicaltrails.gov；NCT05698134.Results从 2021 年 8 月到 2023 年 1 月，共招募了 40 名患者（ROTEM（n = 20）和 SOC（n = 20））。由于ROTEM组在预定的中期分析后获得了令人信服的疗效，该试验在中期分析期间提前终止。ROTEM 组所需输血量大大低于 SOC 组（40% [8/20] vs 100% [20/20]，P < 0.001）。所有类型的血液制品，包括新鲜冰冻血浆（<0.001）和集合血小板（P = 0.046），都能带来一致的益处。没有患者发生有临床意义的出血事件。SOC组有一名患者（5%）发生输血相关不良事件（过敏反应），而ROTEM组则没有（P = NS）。结论ROTEM等黏弹性试验可对肝硬化患者的止血情况进行全面评估。临床试验编号NCT05698134。

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

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.