Analysis of the Activity of Different Coagulation Factors and Monitoring of Coagulation Using Point-of-care Devices During a Veno-venous ECMO Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes in the activity of coagulation factor XIII [%] during Veno-venous ECMO
研究概览
简要总结
Hemorrhagic and thromboembolic complications are common in Veno-venous ECMO therapy. The aim of this study is to provide a detailed analysis of the activity of different coagulation factors and changes in functional coagulation measurements as in rotational thrombelastometry and multiple electrode aggregometry in the course of ECMO therapy.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Need for a Veno-venous extracorporeal membrane oxygenation therapy
排除标准
- •Known coagulation disorders
- •Refusal to participate
结局指标
主要结局
Changes in the activity of coagulation factor XIII [%] during Veno-venous ECMO
时间窗: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Repeated assessment of the activity of coagulation factor XIII in % through standard coagulometric methods.
Changes in the activity of coagulation factor XII [%] during Veno-venous ECMO
时间窗: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Repeated assessment of the activity of coagulation factor XII in % through standard coagulometric methods.
Changes in the activity of coagulation factor II [%] during Veno-venous ECMO therapy
时间窗: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Repeated assessment of the activity of coagulation factor II in % through standard coagulometric methods.
Changes in the activity of coagulation factor VIII [%] during Veno-venous ECMO
时间窗: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Repeated assessment of the activity of coagulation factor VIII in % through standard coagulometric methods.
Changes in the activity of coagulation factor IX [%] during Veno-venous ECMO
时间窗: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Repeated assessment of the activity of coagulation factor IX in % through standard coagulometric methods.
Changes in the activity of coagulation factor VII [%] during Veno-venous ECMO
时间窗: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Repeated assessment of the activity of coagulation factor VII in % through standard coagulometric methods.
Changes in the activity of coagulation factor V [%] during Veno-venous ECMO
时间窗: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Repeated assessment of the activity of coagulation factor V in % through standard coagulometric methods.
Changes in the activity of coagulation factor X [%] during Veno-venous ECMO
时间窗: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Repeated assessment of the activity of coagulation factor X in % through standard coagulometric methods.
次要结局
- vWF-Antigen(Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation)
- Changes in the vWF:Ristocetin-Cofaktor-Activity in % during Veno-venous ECMO therapy(Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation)
- Changes in CFT-EXTEM(Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation)
- Changes in CFT-FIBTEM(Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation)
- Changes in CT-EXTEM(Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation)
- Changes in CT-INTEM(Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation)
- Changes in CT-FIBTEM(Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation)
- Changes in CT-HEPTEM(Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation)
- Changes in CFT-INTEM(Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation)
- Changes in CFT-HEPTEM(Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation)
- Changes in MCF-EXTEM(Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation)
- Changes in Alpha angle-EXTEM(Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation)
- Changes in MCF-INTEM(Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation)
- Changes in MCF-FIBTEM(Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation)
- Changes in adenosine diphosphate (ADP) induced platelet aggregation assessed by multiple elcetrode aggregometry (MEA)(ADPtest)(Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation)
- Quick(Pre-canulation, 6 hours and daily from day 1- day 21after canulation)
- Changes in MCF-HEPTEM(Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation)
- Changes in Alpha angle-INTEM(Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation)
- Changes in Alpha angle-FIBTEM(Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation)
- Changes in Alpha angle-HEPTEM(Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation)
- Changes in arachidonic acid induced platelet aggregation assessed by multiple elcetrode aggregometry (MEA)(ASPItest)(Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation)
- Changes in thrombin-receptor activating peptide (TRAP) induced platelet aggregation assessed by multiple elcetrode aggregometry (MEA)(TRAPtest)(Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation)
- Light transmission aggregometry(6 hours and 7 days after canulation)
- activated partial thromboplastin time (aPTT)(Pre-canulation, 6 hours and daily from day 1- day 21after canulation)
- Fibrinogen(Pre-canulation, 6 hours and daily from day 1- day 21after canulation)
- Platelet count(Pre-canulation, 6 hours and daily from day 1- day 21after canulation)
- activated clotting time (ACT)(Pre-canulation, 6 hours and daily from day 1- day 21after canulation)
- Antithrombin III (ATIII)(Pre-canulation, 6 hours and daily from day 1- day 21after canulation)
- D-Dimers(Pre-canulation, 6 hours, 1 day, 2 days, 3 days, 4 days, 5, days, 6 days, 7 days, 10, days, 11 days 14 days, 17 days, 19 days and 21 days after canulation)
- hemoglobin(Pre-canulation, 6 hours and daily from day 1- day 21after canulation)
- Measurement of Anti-Xa-Activity in %(Pre-canulation, 6 hours, 1 day, 2 days, 3 days, 4 days, 5, days, 6 days, 7 days, 10, days, 11 days 14 days, 17 days, 19 days and 21 days after canulation)
- leucocyte count(Pre-canulation, 6 hours and daily from day 1- day 21after canulation)
- Hemorrhagic complications(Daily from day 1-21)
- Thrombotic complications(Daily from day 1-21)
- Oxygenator State(Daily from day 1-21)
研究者
Saskia Wand
Resident for Anesthesiology, Principal Investigator
University Hospital Goettingen