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与试验相关的血液采样和红细胞输血在早产婴儿
Anna Elisabet Lewis1,2, Susanne S Kappel1,3, Samya Hussain1
1Comparative Pediatrics and Nutrition, University of Copenhagen, Copenhagen, Denmark.
Acta paediatrica (Oslo, Norway : 1992)
|August 11, 2023
概括
非常早产婴儿的试验血液采样不会增加对红细胞 (RBC) 输血的需求. 遵守欧洲伦理准则确保与试验相关的血液抽取是安全的,不会增加临床失血负担.
科学领域:
- 新生儿研究新生儿研究
- 儿科血液学 儿科血液学
- 临床试验 临床试验
背景情况:
- 在非常早产婴儿的临床血液采样有助于血液流失,可能增加对红细胞 (RBC) 输血的需求.
- 评估用于研究的额外抽血的影响对于婴儿安全至关重要.
研究的目的:
- 评估与试验相关的血液采样是否会增加非常早产婴儿后续红细胞输血的风险.
- 为了确定新生儿临床试验中为研究目的抽取的血液体积的安全性和影响.
主要方法:
- 在FortiColos试验 (NCT03537365) 中分析了193名非常早产婴儿的队列.
- 检查了医疗记录,以量化临床和试验相关的血液样本量 (毫升/千克).
- 数据与生命的前28天内红细胞输血需求相关联.
主要成果:
- 与试验相关的血液采样占抽取总血液量 (8.1 ± 5.1 mL/kg) 的很小比例 (1.6 ± 0.6 mL/kg).
- 没有观察到与试验相关的血液采样对红细胞输血需要的统计学意义上的影响 (p=0.9).
结论:
- 根据欧洲伦理标准进行的与试验相关的血液采样,不会对非常早产婴儿在红细胞输血方面造成额外的负担.
- 该研究支持在新生儿研究中纳入试验特定血液采样的安全性,如果严格遵守伦理准则.
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