The Complement Lectin Pathway in Patients Resuscitated After Cardiac Arrest
试验速览
- 阶段
- 不适用
- 入组人数
- 82
- 试验地点
- 6
- 主要终点
- MASP-2 concentration in plasma
研究概览
简要总结
This study includes comatose survivors of out-of-hospital cardiac arrest treated with 24 hours or 48 hours of targeted temperature management.
The overall aim is to evaluate the importance of plasma complement protein concentrations in patients resuscitated after out-of-hospital cardiac arrest and treated with 24 hours or 48 hours of targeted temperature management.
The specific aim is to evaluate:
- the concentration of plasma lectin pathway proteins the first, second and third day after cardiac arrest
- the relation between concentration of plasma lectin pathway proteins and mortality
- if prolonged targeted temperature management influences the concentration of plasma lectin pathway proteins
This study is a sub-study to the trial entitled: "Time-differentiated targeted temperature management (TTH48) (ClinicalTrials.gov Identifier: NCT01689077)"
The following Complement Lectin Pathway proteins will be measured: Mannan-Binding-Lectin, M-ficolin, H-ficolin, CL-L1, MASP-1, MASP-2, MASP-3, MAp19 and MAp44.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Out-of-Hospital Cardiac Arrest of presumed cardiac cause
- •Return of spontaneous circulation (ROSC)
- •Glasgow Coma Score < 8
- •Age > 18 years and < 80 years
排除标准
- •> 60 minutes from the circulatory collapse to ROSC
- •Time interval > 4 hours from cardiac arrest to initiation of targeted temperature management
- •Terminal illness
- •Coagulation disorder
- •Unwitnessed asystolia
- •Cerebral performance category 3-4 before the cardiac arrest
- •Severe persistent cardiogenic shock
- •Pregnancy
- •Persistent cardiogenic shock (systolic bloodpressure < 80 despite inotropic treatment)
- •New apoplexy or cerebral hemorrhage
- •Lack of consent from the relatives
- •Lack of consent from the general practitioner
- •Lack of consent from the patient
结局指标
主要结局
MASP-2 concentration in plasma
时间窗: 48 hours
次要结局
- MASP-2 concentration in plasma(24 hours to 72 hours)
- MASP-1 concentration in plasma(24 hours, 48 hours, 72 hours)
- MASP-3 concentration in plasma(24 hours, 48 hours, 72 hours)
- Mannan-Binding-Lectin concentration in plasma(24 hours, 48 hours, 72 hours)
- MAp44 concentration in plasma(24 hours, 48 hours, 72 hours)
- Map44 concentration in plasma(24 hours to 72 hours)
- MAp19 concentration in plasma(24 hours, 48 hours, 72 hours)
- H-ficolin concentration in plasma(24 hours, 48 hours, 72 hours)
- M-ficolin concentration in plasma(24 hours, 48 hours, 72 hours)
- CL-L1 concentration in plasma(24 hours, 48 hours, 72 hours)