NCT02050230终止4 期
Hemodynamic Effects of Stored Blood Transfusion in Intensive Care Patients
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Pulmonary arterial pressure
研究概览
简要总结
Transfusion of stored blood has been associated with increased pulmonary vascular resistance in lambs. The investigators hypothesize that transfusion of one unit of red blood cells stored under standard conditions in intensive care patients will increase pulmonary arterial pressure and pulmonary vascular resistance to a greater extent than will one unit of fresh red blood cells.
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
- Triple (Participant, Care Provider, Investigator)
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
- •The patient has a pulmonary artery catheter in place
- •Transfusion of 1 unit of packed red blood cells indicated for standard intensive care therapy
- •The patient has an arterial catheter
排除标准
- •Age < 18 years
- •Clinical prediction that the patient will not survive at least 48 hours
- •Acute bleeding: > 2 units of packed red blood cells/hour
- •Vasopressor use: noradrenalin > 0.2 μg/kg/min or any use of adrenalin within 6 hours of inclusion into the study
- •Therapy with inhaled NO, inhaled prostacyclin, or phosphodiesterase-5-inhibitors
结局指标
主要结局
Pulmonary arterial pressure
时间窗: Change from baseline to immediately after transfusion (time frame of 20 min)
Pulmonary vascular resistance
时间窗: Change from baseline to immediately after transfusion (time frame of 20 min)
次要结局
- Systemic pressure(Change from baseline to immediately after transfusion (time frame of 20 min))
- Systemic vascular resistance(Change from baseline to immediately after transfusion (time frame of 20 min))
研究者
David M Baron, MD
MD
Medical University of Vienna
研究点 (2)
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