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
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
- 否
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
