The Perioperative Liberal or Restrictive Transfusion in Pediatric Liver Transplantation: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 488
- 试验地点
- 1
- 主要终点
- Survival rate
研究概览
简要总结
The patients assigned to the restrictive group will receive transfusion once the hemoglobin concentration falls below 6.0 g per deciliter, with a target hemoglobin range of 7.5 to 8.0 g per deciliter. Patients assigned to the liberal group will receive transfusion once the hemoglobin concentration falls below 8.0 g per deciliter, with a target hemoglobin range of 9.0 to 10.0 g per deciliter.
The primary outcome: Survival rate in six months after randomization.
Secondary outcomes: Incidence of perioperative complications, including sepsis , pulmonary complications, portal vein thrombosis, hepatic artery thrombosis and transfusion-related adverse events. Intraoperative blood loss, intraoperative blood transfusion amount, postoperative blood transfusion amount in 7 days after surgery, postoperative inflammatory reaction, mechanical ventilation time in the intensive care unit, lengths of stay in the intensive care unit and the hospital，and hospitalization expenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The investigators study included pediatric patients (the moon's age <36 months) who will receive standard living-donor liver transplantation (LDLT) in Renji Hospital.
排除标准
- •The exclusion criteria of the study were a congenital sufferer from heart, lung, kidney, nervous system or blood disease,active Lung infection, a history of liver transplantation, Multivisceral transplantation, refused to participate the study.
结局指标
主要结局
Survival rate
时间窗: up to 6 months after randomization
次要结局
- Daily score on Pediatric end-stage liver disease (PELD) assessment(up to 7 days after randomization)
- Proportion of patients who need a second hepatic surgery(up to 7 days after randomization)
- Out of pocket expenditure for hospitalization(at discharge, an average of 2 weeks)
- Blood pressure during surgery(during surgery)
- Arterial partial pressure of oxygen during surgery(during surgery)
- Amount of blood transfusion during perioperative period(up to 7 days after surgery)
- Plasma lactic acid concentration during surgery(during surgery)
- Oxygen uptake rate during surgery(during surgery)
- Hospitalization Days(at discharge, an average of 2 weeks)
- Length of Mechanical Ventilation in the intensive care unit(at discharge, an average of 2 weeks)
- Lengths of stay in the intensive care unit(at discharge, an average of 2 weeks)
- Amount of intraoperative blood transfusion(during surgery)
- Heart rate during surgery(during surgery)
- Incidence of severe postoperative complications before discharge(from end of surgery till at discharge, an average of 2 weeks)