Hôpital européen Georges Pompidou
Paris, 75015, France
NCT Number: NCT05079009
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Paris, 75015, France
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").
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Use of the pulsatile extracorporeal blood flow configuration.
Time frame: Up to 30 days
Quantification of plasma Willebrand Factor high molecular weight multimers by the Hydrasys system
Time frame: Up to 30 days
To describe the complications under ECCO2R: hemorrhagic, thrombotic and hemolytic adverse events
Time frame: Up to 30 days
To quantify von Willebrand activity/antigenemy
Time frame: Up to 30 days
Characterization of the blood coagulation system
Time frame: Up to 30 days
Characterization of the blood coagulation system
Time frame: Up to 30 days
Characterization of the blood coagulation system
Time frame: Up to 30 days
Characterization of the blood coagulation system
Time frame: Up to 30 days
Characterization of the blood coagulation system
Time frame: Up to 30 days
Characterization of the blood coagulation system
Time frame: Up to 30 days
Characterization of the blood coagulation system
Time frame: Up to 30 days
Characterization of the blood coagulation system
Time frame: Up to 30 days
Characterization of the blood coagulation system
Time frame: Up to 30 days
Characterization of the blood coagulation system
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
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
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
Time frame: Up to 29 days
Description of the arterial blood gas parameters under ECCO2R
Time frame: Up to 29 days
Description of the arterial blood gas parameters under ECCO2R
Time frame: Up to 29 days
Description of the arterial blood gas parameters under ECCO2R
Time frame: Up to 29 days
Description of the arterial blood gas parameters under ECCO2R
Time frame: Up to 30 days
To describe the patient vital parameters under ECCO2R
Time frame: Up to 30 days
To describe the patient vital parameters under ECCO2R
Time frame: Up to 30 days
To describe the patient vital parameters under ECCO2R
Time frame: Up to 29 days
Description of the ECCO2R parameters
Time frame: Up to 29 days
Description of the ECCO2R parameters
Time frame: Up to 29 days
Description of the ECCO2R parameters
Time frame: Up to 29 days
Description of the ECCO2R parameters
Assistance Publique - Hôpitaux de Paris
Other
Effects of Blood Pulsatility on Von Willebrand Factor During Extracorporeal CO2 Removal (ECCO2R)
Acronym: FLOW-ECCO2R
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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