Effect of Packed Red Blood Cell Transfusion on Eicosanoid Profiles in Plasma of Intensive Care Patients - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Change of plasma eicosanoid concentrations in ICU patients subjected to PRBC Transfusion at any time Point compared to baseline
研究概览
简要总结
The main goal of this pilot study is to assess the time course of eicosanoid profiles in intensive care unit (ICU) patients requiring packed red blood cell (PRBC) transfusion. Moreover we will analyze the change of levels of eicosanoids in patient plasma prior and after a PRBC transfusion as well as its correlation with levels of eicosanoids in the transfused PRBCs. These data will then be used to determine the estimated effect size necessary for the planning of future larger studies. We hypothesize that transfusion of PRBCs will modulate the eicosanoid profile in ICU patients.
According to the Protocol filed with the Institutional Review Board of the Medical University of Vienna and patient's informed consent, subsequent sub analyses using samples of this study (e.g., determination of extracellular vesicles in PRBC samples and patient's plasma) will be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Age <18 years or >99 years
- •Pregnancy
- •<12h since last PRBC transfusion
- •intake/administration of acetylsalicylic acid in groups 2 and 3
- •intake/administration of cysteinyl leukotriene receptor antagonists (e.g. montelukast)
- •intake/administration of celecoxib, etoricoxib, parecoxib, ibuprofen, diclofenac, and naproxen in all groups
- •glucocorticoids given within 24h of transfusion in groups 1 and 3
- •treatment with calcineurin inhibitors (e.g. tacrolimus) in groups 1 and 3
- •treatment with alemtuzumab in groups 1 and 3
- •administration of protamine for heparin reversal in groups 2 and 3
结局指标
主要结局
Change of plasma eicosanoid concentrations in ICU patients subjected to PRBC Transfusion at any time Point compared to baseline
时间窗: 60 minutes prior to 90 minutes after packed red blood cell transfusion
次要结局
- Changes of plasma eicosanoid profiles after PRBC transfusion compared to prior to PRBC transfusion in ICU patients(60 minutes prior to 90 minutes after packed red blood cell transfusion)
- Correlation of plasma eicosanoid profiles in the transfused PRBCs and the change of their plasma levels in ICU patients(60 minutes prior to 90 minutes after packed red blood cell transfusion)
研究者
David M Baron, MD, PhD
Principle Investigator
Medical University of Vienna