NCT06312488已完成不适用
Point of Care Evaluation of Fibrinolysis in Sepsis
Policlinico Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年1月22日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Prevalence of impaired fibrinolysis
研究概览
简要总结
Impaired fibrinolysis in septic patients is associated with worse outcome. The present study investigates fibrinolysis shutdown in septic patients, defined as prolonged ClotPro® TPA lysis time at 30 minutes. The TPA lysis time reference range is established in a cohort of healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •age > 18 years
- •sepsis or septic shock
- •vasopressors required to maintain a MAP ≥ 65 mmHg despite adequate fluid resuscitation
排除标准
- •coagulation disorders
- •ECMO therapy
- •use of oral anticoagulant drugs
研究组 & 干预措施
Healthy volunteers
Other
干预措施: Clot Pro (Diagnostic Test)
Septic patients
Other
干预措施: Clot Pro (Diagnostic Test)
结局指标
主要结局
Prevalence of impaired fibrinolysis
时间窗: Lysis time at 30 minutes at enrollment and on day 1, 2, 3, and 7
Lysis time at 30 minutes longer than 97.5th percentile of the calculated reference range of the ClotPro® TPA test
次要结局
- Correlation between impaired fibrinolysis and changes in coagulation standard tests(Measures are performed at enrollment and on day 1, 2, 3, and 7)
- Correlation between impaired fibrinolysis and ICU lenght of stay(Through study completion, an average of 1 year)
- Correlation between impaired fibrinolysis and inflammation markers(Measures are performed at enrollment and on day 1, 2, 3, and 7)
- Correlation between impaired fibrinolysis and multiorgan failure(Measures are performed at enrollment and on day 1, 2, 3, and 7)
- Correlation between impaired fibrinolysis and ICU mortality(From date of enrollment until date of ICU discharge or date of death from any cause, whichever comes first, assessed up to 1 year)
研究者
Mauro Panigada
Principal Investigator
Policlinico Hospital
研究点 (1)
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