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纤维蛋白原和凝血酶原复合物浓缩剂:时间顺序的重要性——两项随机对照试验的事后分析

Fibrinogen and Prothrombin Complex Concentrate: The Importance of the Temporal Sequence-A Post-Hoc Analysis of Two Randomized Controlled Trials.

作者信息

Ranucci Marco, Aloisio Tommaso, Di Dedda Umberto, Anguissola Martina, Barbaria Alessandro, Baryshnikova Ekaterina

机构信息

Department of Cardiothoracic and Vascular Anesthesia and Intensive Care, Istituto di Ricovero e Cura a Carattere Scientifico, Policlinico San Donato, San Donato Milanese, 20097 Milan, Italy.

出版信息

J Clin Med. 2024 Nov 25;13(23):7137. doi: 10.3390/jcm13237137.

Abstract

: A low level of soluble coagulation factors after cardiac surgery may cause excessive bleeding and trigger clinical correction using prothrombin complex concentrate (PCC). According to the current guidelines, the trigger values for PCC administration are not defined. In the published algorithms, when driven by ROTEM, the triggers vary from 80 s to >100 s of coagulation time (CT) during an EXTEM test. Two randomized controlled trials on fibrinogen (FC) supplementation after cardiac surgery previously pointed out that the patients receiving FC supplementation had a significant decrease in their EXTEM CT. This study investigates the hypothesis that after increasing the availability of a substrate (fibrinogen), thrombin generation induces fibrin network formation faster, and that, before considering PCC administration, the normalization of fibrinogen levels should be sought. : A retrospective study based on a post-hoc analysis of the data collected in two previous RCTs involving 85 patients, all of whom received FC supplementation. : The results of this post-hoc analysis demonstrate that there is a significant negative association between FIBTEM maximum clot firmness (MCF) and the EXTEM CTs before and after FC supplementation; FC supplementation decreases the EXTEM CTs both in patients with a low FIBTEM MCF and a normal FIBTEM MCF. After FC supplementation, 45 (53%) of the patients had an EXTEM CT of >80 s, 22 (26%) had an EXTEM CT of >90 s, and 8 (9%) had an EXTEM CT of >100 s. Our study confirms and quantifies the effects of reducing EXTEM CTs through FC supplementation. A stepwise strategy of factors correction with FC supplementation should be used before considering PCC administration as it might reduce the need for PCC.

摘要

心脏手术后可溶性凝血因子水平较低可能导致出血过多,并引发使用凝血酶原复合物浓缩剂(PCC)进行临床纠正。根据当前指南,PCC给药的触发值尚未明确。在已发表的算法中,由旋转血栓弹力图(ROTEM)驱动时,EXTEM试验期间凝血时间(CT)的触发值从80秒到超过100秒不等。此前两项关于心脏手术后补充纤维蛋白原(FC)的随机对照试验指出,接受FC补充的患者EXTEM CT显著降低。本研究调查了以下假设:增加底物(纤维蛋白原)的可用性后,凝血酶生成会更快地诱导纤维蛋白网络形成,并且在考虑使用PCC之前,应寻求纤维蛋白原水平的正常化。:一项基于对之前两项随机对照试验收集的数据进行事后分析的回顾性研究,这两项试验涉及85名患者,所有患者均接受了FC补充。:这项事后分析的结果表明,FIBTEM最大血凝块硬度(MCF)与补充FC前后的EXTEM CT之间存在显著的负相关;补充FC可降低FIBTEM MCF低和FIBTEM MCF正常的患者的EXTEM CT。补充FC后,45名(53%)患者的EXTEM CT>80秒,22名(26%)患者的EXTEM CT>90秒,8名(9%)患者的EXTEM CT>100秒。我们的研究证实并量化了通过补充FC降低EXTEM CT的效果。在考虑使用PCC之前,应采用补充FC的逐步因子纠正策略,因为这可能会减少对PCC的需求。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c2d8/11642716/2c70dfa7bb09/jcm-13-07137-g001.jpg

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