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临床试验/NCT04927988
NCT04927988撤回不适用

Blood Components Changes by Using of Ringer's Lactated as Detergent In Autologous Blood Cell Transfusion: A Prospective, Single-center, Open, and Single-arm Clinical Trial

Maternal and Child Health Hospital of Foshan1 个研究点 分布在 1 个国家开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Change in hematological parameters

研究概览

简要总结

Placenta accreta spectrum (PAS) disorders are associated with increased maternal morbidity and mortality related to life-threatening hemorrhage, and greater potential need for blood transfusion. Clinical evidences have confirmed that the use of autologous blood cell transfusion is safe and effective for patients with obstetric haemorrhage. Normal saline is the solution recommended for red cell washing, administration and salvage. However, there is growing concern that normal saline is more toxic than balanced, buffered crystalloids such as Lactated Ringer's and Plasma-Lyte. The purpose of this study is to evaluate the blood components using of Ringer's Lactated by a prospective, single-center, open, and single-arm clinical trial.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Between 18 and 45 years old
  • Without health problem nor disease requiring regular medical treatment

排除标准

  • subject with contraindication for drawing blood
  • Subject with physical or mental disability or restriction of liberty that would prevent autotransfusion

结局指标

主要结局

Change in hematological parameters

时间窗: Baseline (Day 1), until 2 days after autotransfusion

erythrocytes (/µL)

次要结局

未报告次要终点

研究者

发起方
Maternal and Child Health Hospital of Foshan
申办方类型
Other
责任方
Sponsor

研究点 (1)

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