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临床试验/NCT05267145
NCT05267145Unknown不适用

The Protection of Blood Preservation Solution III on Erythrocytes in Intraoperative Blood Salvage During Cardiopulmonary Bypass

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
hemoglobin and free hemoglobin concentrations

研究概览

简要总结

To evaluate the effects of blood preservation solution III (sodium citrate, sodium dihydrogen phosphate, sodium citrate, glucose and adenine) in autologous blood recovery and storage bags on the metabolic morphological functions and characteristics of red blood cells in patients undergoing cardiac surgery supported by cardiopulmonary bypass

详细描述

Blood preservation solution III is a blood protective solution clinically used to store whole blood and red blood cells. It is a sterilized aqueous solution composed of sodium citrate dihydrogen phosphate sodium citrate glucose and adenine, in which glucose adenine can provide the required energy for stored RBC. Citric acid/sodium citrate buffer pair can adjust the pH of RBC suspension; Sodium dihydrogen phosphate can prevent RBC aggregation, provide phosphate for RBC energy metabolism, and slow down the decline rate of 2,3-DPG. Blood preservation solution III can reduce RBC destruction and protect its function. Therefore, this study aims to explore the effect of adding blood preservation solution III in blood storage bags on CPB Influence of autologous blood recovery RBC during cardiac surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • Elective median incision for cardiac surgery under CPB ASAⅠ~Ⅲ Intraoperative blood recovery is pollution-free No blood system diseases, no red blood cell related diseases Preoperative blood routine examination showed no obvious abnormalities in blood coagulation function and biochemistry

排除标准

  • Patients have malignant tumor Patients are complicated with systemic infectious disease Intraoperative blood loss is expected to be less than 200ml Patients receiving allogeneic red blood cells during operation

结局指标

主要结局

hemoglobin and free hemoglobin concentrations

时间窗: up to 48 hours

hemoglobin and free hemoglobin concentrations in both groups

次要结局

  • RBC morphology(autologous blood transfusion immediately, 24 hours, 48 hours)
  • Adenosine acid (ATP ADP AMP) content in RBC(autologous blood transfusion immediately, 24 hours, 48 hours)
  • 2, 3-diphosphate (2,3-DPG) concentration(autologous blood transfusion immediately, 24 hours, 48 hours)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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