Baryshnikova Ekaterina, Aloisio Tommaso, Di Dedda Umberto, Anguissola Martina, Barbaria Alessandro, Caravella Giuseppe, Ranucci Marco
From the Departments of Cardiovascular Anesthesia and Intensive Care.
Pharmacy Service, IRCCS Policlinico San Donato, San Donato Milanese (Milan), Italy.
Anesth Analg. 2025 Apr 1;140(4):966-973. doi: 10.1213/ANE.0000000000007201. Epub 2024 Oct 9.
Different preparations of fibrinogen concentrate are currently available. Two in vitro studies demonstrated the superiority of FibCLOT (LFB) in increasing clot firmness with respect to RiaSTAP (CSL Behring). The present trial involved a clinical model to test the hypothesis of superiority, with the increase in clot firmness as the primary end point.
Forty cardiac surgery patients were randomly allocated to receive a dose of 30 mg/kg FibCLOT or RiaSTAP after protamine administration in the presence of microvascular bleeding and a FIBTEM maximum clot firmness (MCF) <10 mm. Viscoelastic parameters were measured before and after fibrinogen supplementation: FIBTEM MCF, EXTEM MCF, and EXTEM clotting time (CT).
The mean increase in FIBTEM MCF was 4 ± 1.2 mm (mean and standard deviation) in the FibCLOT group and 4 ± 1.6 mm in the RiaSTAP group ( P = 1.000); the mean decrease in CT was 11. 2 ± 12.2 (mean and standard deviation) seconds in the FibCLOT group and 14. 8 ± 13 seconds in the RiaSTAP group ( P = .372). In both groups, fibrinogen supplementation induced a significant ( P = .001) increase in the FIBTEM MCF and EXTEM CT. The proportions of patients who did not experience an increase of 4 mm in the RiaSTAP group and the FibCLOT group were not statistically significantly higher (35% vs 20%, respectively, relative risk 2.15, 95% confidence interval 0.52-9.00, P = .288).
In contrast to previous in vitro studies, we found that the effect of FibCLOT on MCF and CT was not significantly greater than that of RiaSTAP in cardiac surgery patients. Further studies in other clinical settings are warranted.
目前有不同制剂的纤维蛋白原浓缩物。两项体外研究表明，与瑞斯托酶原（CSL Behring公司）相比，FibCLOT（LFB公司）在增加血凝块硬度方面具有优势。本试验采用临床模型来检验优势假设，以血凝块硬度增加作为主要终点。
40例心脏手术患者在存在微血管出血且FIBTEM最大血凝块硬度（MCF）<10 mm的情况下，在给予鱼精蛋白后随机分配接受30 mg/kg剂量的FibCLOT或瑞斯托酶原。在补充纤维蛋白原之前和之后测量粘弹性参数：FIBTEM MCF、EXTEM MCF和EXTEM凝血时间（CT）。
FibCLOT组FIBTEM MCF的平均增加为4±1.2 mm（均值和标准差），瑞斯托酶原组为4±1.6 mm（P = 1.000）；FibCLOT组CT的平均减少为11.2±12.2（均值和标准差）秒，瑞斯托酶原组为14.8±13秒（P = 0.372）。在两组中，补充纤维蛋白原均导致FIBTEM MCF和EXTEM CT显著增加（P = 0.001）。瑞斯托酶原组和FibCLOT组中血凝块硬度未增加4 mm的患者比例无统计学显著差异（分别为35%和20%，相对风险2.15，95%置信区间0.52 - 9.00，P = 0.288）。
与之前的体外研究相反，我们发现在心脏手术患者中，FibCLOT对MCF和CT的影响并不显著大于瑞斯托酶原。有必要在其他临床环境中进行进一步研究。
