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Completed

NCT Number: NCT05079009

Effects of Blood Pulsatility on Von Willebrand Factor During ECCO2R

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).

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Key information

About this study

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").

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

ECCO2R pulsatile configuration

Device

Use of the pulsatile extracorporeal blood flow configuration.

Primary outcomes

  1. Level course of Willebrand Factor high molecular weight multimers in plasma

    Time frame: Up to 30 days

    Quantification of plasma Willebrand Factor high molecular weight multimers by the Hydrasys system

Secondary outcomes

  1. Rate of specific adverse events

    Time frame: Up to 30 days

    To describe the complications under ECCO2R: hemorrhagic, thrombotic and hemolytic adverse events

  2. Level of von Willebrand factor

    Time frame: Up to 30 days

    To quantify von Willebrand activity/antigenemy

  3. Level of P-Selectin

    Time frame: Up to 30 days

    Characterization of the blood coagulation system

  4. Level of leucoplatelet aggregates

    Time frame: Up to 30 days

    Characterization of the blood coagulation system

  5. Level of proplatelet aggregates

    Time frame: Up to 30 days

    Characterization of the blood coagulation system

  6. Level of platelet

    Time frame: Up to 30 days

    Characterization of the blood coagulation system

  7. Level of microparticles

    Time frame: Up to 30 days

    Characterization of the blood coagulation system

  8. Level of leucocytes

    Time frame: Up to 30 days

    Characterization of the blood coagulation system

  9. Level of endothelial cells

    Time frame: Up to 30 days

    Characterization of the blood coagulation system

  10. Level of NETs (Neutrophil Extracellular Traps)

    Time frame: Up to 30 days

    Characterization of the blood coagulation system

  11. Level of free DNA

    Time frame: Up to 30 days

    Characterization of the blood coagulation system

  12. Level of Nucleosome

    Time frame: Up to 30 days

    Characterization of the blood coagulation system

  13. Level of FiO2

    Time frame: 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

  14. VT (Tidal Volume)

    Time frame: 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

  15. Respiratory rate

    Time frame: 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

  16. Level of PaO2

    Time frame: Up to 29 days

    Description of the arterial blood gas parameters under ECCO2R

  17. Level of PaCO2

    Time frame: Up to 29 days

    Description of the arterial blood gas parameters under ECCO2R

  18. pH

    Time frame: Up to 29 days

    Description of the arterial blood gas parameters under ECCO2R

  19. Level of SaO2

    Time frame: Up to 29 days

    Description of the arterial blood gas parameters under ECCO2R

  20. Heart rate

    Time frame: Up to 30 days

    To describe the patient vital parameters under ECCO2R

  21. Respiratory rate

    Time frame: Up to 30 days

    To describe the patient vital parameters under ECCO2R

  22. Blood Pressure

    Time frame: Up to 30 days

    To describe the patient vital parameters under ECCO2R

  23. Pump speed

    Time frame: Up to 29 days

    Description of the ECCO2R parameters

  24. Pulsatility setting

    Time frame: Up to 29 days

    Description of the ECCO2R parameters

  25. Extracorporal blood flow

    Time frame: Up to 29 days

    Description of the ECCO2R parameters

  26. Extracorporal pressures

    Time frame: Up to 29 days

    Description of the ECCO2R parameters

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Xenios AG

Registry information

Official study title

Effects of Blood Pulsatility on Von Willebrand Factor During Extracorporeal CO2 Removal (ECCO2R)

Acronym: FLOW-ECCO2R

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 15, 2021
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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