A Randomized, Controlled Pilot Trial of Transfusion Requirements After Orthotopic Liver
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Composite of death, graft loss and renal failure
研究概览
简要总结
The objective of this trial is to evaluate different transfusion strategies in patients after liver transplantation. Patients in the experimental arm will be given red blood cell (RBC) transfusion according to a liberal strategy, i. e., transfusions should be given, when hemoglobin concentration falls below 10 g/dl, and hemoglobin concentration should be maintained between 10 and 12 g/dl. Patients in the control arm will be given red blood cell (RBC) transfusion according to a restrictive strategy, i. e., transfusions should be given, when hemoglobin concentration falls below 8 g/dl, and hemoglobin concentration should be maintained between 8 and 10 g/dl.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing liver transplantation
- •Patients considered to have euvolemia after initial treatment by attending physicians
排除标准
- •Patients age 18 or less
- •Patients undergoing combined liver-kidney transplantation
- •Patients requiring renal replacement therapy before liver transplantation for longer than two weeks
- •Inability to receive blood products
- •Patient with active blood loss at the time of enrollment
- •Pregnancy
- •Imminent death
结局指标
主要结局
Composite of death, graft loss and renal failure
时间窗: 30 days after randomization
次要结局
- Renal function(30 days after randomization)
研究者
Karsten Gavenis
Dr.
University Medical Center Goettingen