与内素 (CRETE) 相关的早期血栓预防研究协议 (CRETE) 研究
E Vincent S Faustino1, Sarah B Kandil1, Matthew K Leroue2
1Department of Pediatrics, Yale School of Medicine, New Haven, CT.
概括
埃诺沙巴林预防有效地减少了中静脉导管相关的深静脉血栓在危急病的老年儿童,但不是婴儿. 在CRETE研究中,研究了因年龄而异的埃诺沙巴林在预防CADVT方面的疗效差异.
科学领域:
- 儿科重症监护医学 儿科重症监护医学
- 药理学和治疗学 药理学和治疗学
- 血栓形成和血液静止.
背景情况:
- 之前的研究表明,素预防可减少中枢静脉导管 (CVC) 相关的深静脉血栓 (CADVT) 在危急病的老年儿童中.
- 然而,这种益处没有在婴儿中观察到,这表明因年龄而异的沙的疗效.
研究的目的:
- 调查因年龄而异的埃诺沙巴林预防疗法的有效性,以预防重症儿童的CADVT.
- 进一步阐明这些年龄特定反应背后的机制.
主要方法:
- 两个平行,多中心的贝叶斯优势解释性随机临床试验 (RCT) 针对年龄较大的儿童 (阶段3) 和婴儿 (阶段2b).
- 一个探索性机械嵌套病例控制研究.
- 参与者:重症儿童 (较大的儿童1-17岁;婴儿<1岁修正年龄) 患有新的CVC,不包括有出血风险的儿童.
主要成果:
- 较大的儿童被随机分为2:1给予埃诺沙巴林或通常护理;婴儿被随机分为1:1:1给予两个埃诺沙巴林抗Xa范围或通常护理.
- 通过超声波评估的首要结局,在CVC被切除后用于CADVT.
- 二次结局包括出血事件和血栓生成标志物.
结论:
- 克雷特研究旨在澄清埃诺沙巴林在不同儿科年龄组预防CADVT中的作用.
- 研究结果将为患有CVC的重症儿童提供最佳的血栓预防策略.
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