Effects of Blood Pulsatility on Von Willebrand Factor During Extracorporeal CO2 Removal (ECCO2R)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Level course of Willebrand Factor high molecular weight multimers in plasma
研究概览
简要总结
The primary objective of the study is to demonstrate that the ECCO2R pulsatile configuration prevents the Willebrand factor high molecular weight multimers decrease observed under continuous blood flow configurations.
The secondary objectives are to quantify the CO2 extracorporeal removal in the pulsatile configuration, to describe complications (hemorrhagic, thrombotic and hemolytic), to describe patients' gas exchanges under ECCO2R, to describe the clinical course of the patients under ECCO2R as well as during the whole stay in the Intensive Care Unit (ICU).
详细描述
A track of major interest to prevent bleeding complications in ECCO2R, and more generally in extracorporeal circulations, is to prevent acquired Willebrand disease. Indeed, a loss of Willebrand factor high molecular weight multimers (Whmwm) is frequently observed in conditions characterized by a continuous blood flow, associated with a high incidence of bleeding. A publication suggested the existence of this phenomenon under ECCO2R achieved through the medical device Hemolung (Alung technology, USA). We preliminary observed an almost constant and early (< 24 hours) decrease in Willebrand factor high molecular weight multimers under ECCO2R. Such a phenomenon is considered as a major factor of hemorrhagic complications. We hypothesize that use of pulsatile extracorporeal blood flow configuration during the full length of ECCO2R therapy, as authorized by the Xenios console (Xenios AG, Heilbronn), would preserve a normal value of Whmwm, mainly by changing the conditions of shear constraints ("shear stress").
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Adult patient hospitalized in the Georges Pompidou European Hospital medical ICU
- •Patient with or without SARS-CoV-2 infection
- •ECCO2R treatment decision made by the medical team (regardless of the FLOW-ECCO2R protocol): mainly ECCO2R to enable ultraprotective ventilation for Acute respiratory distress syndrome (ARDS) patients or to avoid intubation or to shorten invasive mechanical ventilation in Chronic obstructive pulmonary disease (COPD) patients
- •Affiliation to a social security regimen
- •Informed consent (patient, trusted person, close family) , by default emergency inclusion notified in medical file and pursuance consent sought
- •Negative serum or urinary β-hCG for women of child-bearing potential
排除标准
- •Known allergy to heparin or to any of the excipients of the specialty used
- •History of type II heparin-induced thrombopenia
- •Thrombocytopenia (platelet < 100.000/mm3)
- •Constitutional hemostasis disease interfering with biological assays
- •Organic lesion likely to bleed
- •Bleeding manifestations or tendencies linked to disorders of hemostasis
- •Intracerebral hemorrhage
- •Participation in another interventional research involving human participants
- •Pregnant or breastfeeding women
- •Protected adults (including individual under guardianship by court order)
- •Persons deprived of their liberty by judicial or administrative decision
结局指标
主要结局
Level course of Willebrand Factor high molecular weight multimers in plasma
时间窗: Up to 30 days
Quantification of plasma Willebrand Factor high molecular weight multimers by the Hydrasys system
次要结局
- Rate of specific adverse events(Up to 30 days)
- Level of von Willebrand factor(Up to 30 days)
- Level of microparticles(Up to 30 days)
- Level of endothelial cells(Up to 30 days)
- Level of proplatelet aggregates(Up to 30 days)
- Level of leucoplatelet aggregates(Up to 30 days)
- Level of platelet(Up to 30 days)
- Level of P-Selectin(Up to 30 days)
- Level of leucocytes(Up to 30 days)
- Level of NETs (Neutrophil Extracellular Traps)(Up to 30 days)
- Level of Nucleosome(Up to 30 days)
- VT (Tidal Volume)(Up to 29 days)
- Level of PaCO2(Up to 29 days)
- Pulsatility setting(Up to 29 days)
- Level of free DNA(Up to 30 days)
- Pump speed(Up to 29 days)
- Extracorporal pressures(Up to 29 days)
- Level of FiO2(Up to 29 days)
- Respiratory rate(Up to 30 days)
- Level of PaO2(Up to 29 days)
- Heart rate(Up to 30 days)
- Blood Pressure(Up to 30 days)
- Extracorporal blood flow(Up to 29 days)
- pH(Up to 29 days)
- Level of SaO2(Up to 29 days)