NCT03968484撤回不适用
Platelet Transfusion in Sepsis Trial (PlaTiSep)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Overall survival in 90 day follow-up period
研究概览
简要总结
Platelets are important mediators of an inflammatory response and a key component of the innate immune system to defend the human body against invading pathogens. However, little evidence exists regarding the number of platelets that should be used als transfusion threshold in septic patients. In this trial platelet transfusion will be performed with either <50000/µl or <20000/µl as a trigger.
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
- None
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
- •Sepsis defined as alteration of SOFA score (Sepsis-related organ failure assessment score) >2 points (Sepsis-3 definition)
- •platelet count <50.000/µl
排除标准
- •Age less than 18 years
- •patients with immune thrombocytopenia
- •major bleeding in the last 72 hours or ongoing major bleeding
- •patient, surrogate or physician not committed to full intensive care support
- •pregnancy
结局指标
主要结局
Overall survival in 90 day follow-up period
时间窗: 90 days
overall survival at 90 days
次要结局
- all cause mortality at 6 months(6 months)
- duration of mechanical ventilation support(28 days)
- resolution of shock(5 days)
- ICU length of stay(28 days)
- renal replacement therapy(28 days)
- bleeding events(28 days)
- SOFA score(28 days)
- discharge location(90 days)
研究者
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