一个随机对照试验,比较不同纤维素原剂制剂在恢复凝块牢固性的有效性
Ekaterina Baryshnikova1, Tommaso Aloisio1, Umberto Di Dedda1
1From the Departments of Cardiovascular Anesthesia and Intensive Care.
Anesthesia and analgesia
|October 9, 2024
概括
在心脏外科手术中,FibCLOT没有比RiaSTAP显著改善凝块坚固度. 这项临床试验发现,这两种纤维素原缩物对血液凝固参数具有相似的影响.
科学领域:
- 麻醉学 麻醉学
- 血液学 血液学 血液学
- 心血管外科心血管外科
背景情况:
- 纤维素缩剂的制备有所不同,体外研究表明,FibCLOT在增强凝块坚固性方面优于RiaSTAP.
- 用一个临床模型来评估FibCLOT和RiaSTAP的比较疗效.
研究的目的:
- 测试FibCLOT在增加心脏手术患者的凝块坚固性方面优于RiaSTAP的假设.
- 为了比较FibCLOT和RiaSTAP对粘弹性参数的影响,特别是FIBTEM最大凝块坚度 (MCF) 和EXTEM凝结时间 (CT).
主要方法:
- 40名心脏手术患者患有微血管出血和FIBTEM MCF<10毫米,接受了FibCLOT或RiaSTAP (30毫克/公斤) 的前胺类药物后给药.
- 粘弹性参数,包括FIBTEM MCF,EXTEM MCF和EXTEM CT,在纤维素缩物注射前后进行测量.
主要成果:
- 在FibCLOT (4±1.2毫米) 和RiaSTAP (4±1.6毫米) 组之间,FIBTEM MCF的平均增加是可比的 (P=1.000).
- 在EXTEMCT中平均降低也是相似的:FibCLOT的11.2 ± 12.2秒,RiaSTAP的14.8 ± 13秒 (P = .372).
- 这两种度都显著增加了FIBTEM MCF和EXTEM CT (P = .001),在患者中没有达到4毫米MCF增加的比例上没有统计学上显著的差异 (20%对35%,P = .288).
结论:
- 与体外发现相反,FibCLOT在这种临床环境中没有显示出比RiaSTAP在改善凝块稳定性或凝块时间方面显著更大的有效性.
- 需要进一步的研究来研究这些纤维素缩物在不同临床场景中的比较性能.
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