Effects of Blood Pulsatility on Von Willebrand Factor During ECCO2R
- Conditions
- Acute Respiratory Distress SyndromeChronic Obstructive Pulmonary Disease ExacerbationPulmonary DiseaseExtracorporeal CO2 Removal
- Interventions
- Device: ECCO2R pulsatile configuration
- Registration Number
- NCT05079009
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
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).
- Detailed Description
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").
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ECCO2R pulsatile configuration ECCO2R pulsatile configuration Adult patients hospitalized in the medical ICU for whom a treatment by ECCO2R has been indicated.
- Primary Outcome Measures
Name Time Method Level course of Willebrand Factor high molecular weight multimers in plasma Up to 30 days Quantification of plasma Willebrand Factor high molecular weight multimers by the Hydrasys system
- Secondary Outcome Measures
Name Time Method Rate of specific adverse events Up to 30 days To describe the complications under ECCO2R: hemorrhagic, thrombotic and hemolytic adverse events
Level of von Willebrand factor Up to 30 days To quantify von Willebrand activity/antigenemy
Level of microparticles Up to 30 days Characterization of the blood coagulation system
Level of endothelial cells Up to 30 days Characterization of the blood coagulation system
Level of proplatelet aggregates Up to 30 days Characterization of the blood coagulation system
Level of leucoplatelet aggregates Up to 30 days Characterization of the blood coagulation system
Level of platelet Up to 30 days Characterization of the blood coagulation system
Level of P-Selectin Up to 30 days Characterization of the blood coagulation system
Level of leucocytes Up to 30 days Characterization of the blood coagulation system
Level of NETs (Neutrophil Extracellular Traps) Up to 30 days Characterization of the blood coagulation system
Level of Nucleosome Up to 30 days Characterization of the blood coagulation system
VT (Tidal Volume) Up to 29 days Recording of mechanical ventilator parameters (Non-Invasive Ventilation or Invasive Mechanical Ventilation) to describe the patients' clinical course under ECCO2R as well as during the whole stay in the ICU.v
Level of PaCO2 Up to 29 days Description of the arterial blood gas parameters under ECCO2R
Pulsatility setting Up to 29 days Description of the ECCO2R parameters
Level of free DNA Up to 30 days Characterization of the blood coagulation system
Pump speed Up to 29 days Description of the ECCO2R parameters
Extracorporal pressures Up to 29 days Description of the ECCO2R parameters
Level of FiO2 Up to 29 days Recording of mechanical ventilator parameters (Non-Invasive Ventilation or Invasive Mechanical Ventilation) to describe the patients' clinical course under ECCO2R as well as during the whole stay in the ICU.v
Respiratory rate Up to 30 days To describe the patient vital parameters under ECCO2R
Level of PaO2 Up to 29 days Description of the arterial blood gas parameters under ECCO2R
Heart rate Up to 30 days To describe the patient vital parameters under ECCO2R
Blood Pressure Up to 30 days To describe the patient vital parameters under ECCO2R
Extracorporal blood flow Up to 29 days Description of the ECCO2R parameters
pH Up to 29 days Description of the arterial blood gas parameters under ECCO2R
Level of SaO2 Up to 29 days Description of the arterial blood gas parameters under ECCO2R
Trial Locations
- Locations (1)
Hôpital européen Georges Pompidou
🇫🇷Paris, France