Pulmonary Hemodynamic Effects of Stored Red Blood Cell Transfusion in Post-Operative Cardiac Surgical Patients: Influence of Breathing Nitric Oxide. A Randomized Controlled Trial in the Cardiac-Intensive Care Unit.
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Pulmonary vascular resistance index
研究概览
简要总结
The objective of this study is to assess if prolonged storage time of a packed red blood cell unit may cause pulmonary vasoconstriction after transfusion, in a susceptible population such as cardiac surgery patients. The investigators will also evaluate the potential reversal effect of Inhaled Nitric Oxide on pulmonary vasoconstriction induced by stored blood transfusions.
详细描述
Patients will be randomized into one of the three groups:
I. Blood transfusion stored for less than 10 days II. Blood transfusion stored for more than 30 days III. Blood transfusion stored for more than 30 days days plus inhalation of Nitric Oxide at 80 part per million for an hour during blood transfusion.
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, Investigator, Outcomes Assessor)
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
- •Provide written informed consent
- •Elective cardiac or aortic surgery
- •One or more blood transfusions scheduled for clinical reasons
- •Presence of an arterial catheter and pulmonary arterial catheter
排除标准
- •Emergent cardiac surgery.
- •Patients requiring irradiated or washed blood transfusions.
研究组 & 干预措施
Old blood transfusion and Nitric Oxide
This randomized group of patients (n=30) will receive leukoreduced blood transfusion stored for more than 30 days while breathing nitric oxide (80 part per million) and oxygen
干预措施: Nitric Oxide (Drug)
结局指标
主要结局
Pulmonary vascular resistance index
时间窗: During and after blood transfusion- average time of observation 6 hours
Parameters to calculate pulmonary vascular resistance index will be measured during and after blood transfusion for about 6 hours. The following parameters will be recorded: height, weight, systemic pressure, pulmonary pressure, wedge pressure, central venous pressure, cardiac output) of each subjects will be recorded.
次要结局
- Inflammation(During and after blood transfusion- average time of observation 6 hours)
- Hemolysis(During and after blood transfusion- average time of observation 6 hours)
- Nitric oxide metabolites(During and after blood transfusion- average time of observation 6 hours)
研究者
Lorenzo Berra, MD
Staff anesthesiologist
Massachusetts General Hospital