Effects of Blood Pulsatility on Von Willebrand Factor During ECCO2R

Acute Respiratory Distress Syndrome Clinical Trial

— FLOW-ECCO2R  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05079009
• Other study ID #: APHP180481
• Secondary ID: DR-2020-3022020-
• Status: Completed
• Phase: N/A
• Start date: January 28, 2022
• Est. completion date: May 16, 2023

Study information

• Verified date: May 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 16, 2023
• Est. primary completion date: May 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Chronic Obstructive Pulmonary Disease Exacerbation
• Disease Progression
• Extracorporeal CO2 Removal
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease
• Pulmonary Disease, Chronic Obstructive
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• ECCO2R pulsatile configuration
Use of the pulsatile extracorporeal blood flow configuration.

Locations

Country	Name	City	State
France	Hôpital européen Georges Pompidou	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Xenios AG

Country where clinical trial is conducted

France, 

References & Publications (1)

Kalbhenn J, Neuffer N, Zieger B, Schmutz A. Is Extracorporeal CO2 Removal Really "Safe" and "Less" Invasive? Observation of Blood Injury and Coagulation Impairment during ECCO2R. ASAIO J. 2017 Sep/Oct;63(5):666-671. doi: 10.1097/MAT.0000000000000544. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level course of Willebrand Factor high molecular weight multimers in plasma	Quantification of plasma Willebrand Factor high molecular weight multimers by the Hydrasys system	Up to 30 days
Secondary	Rate of specific adverse events	To describe the complications under ECCO2R: hemorrhagic, thrombotic and hemolytic adverse events	Up to 30 days
Secondary	Level of von Willebrand factor	To quantify von Willebrand activity/antigenemy	Up to 30 days
Secondary	Level of P-Selectin	Characterization of the blood coagulation system	Up to 30 days
Secondary	Level of leucoplatelet aggregates	Characterization of the blood coagulation system	Up to 30 days
Secondary	Level of proplatelet aggregates	Characterization of the blood coagulation system	Up to 30 days
Secondary	Level of platelet	Characterization of the blood coagulation system	Up to 30 days
Secondary	Level of microparticles	Characterization of the blood coagulation system	Up to 30 days
Secondary	Level of leucocytes	Characterization of the blood coagulation system	Up to 30 days
Secondary	Level of endothelial cells	Characterization of the blood coagulation system	Up to 30 days
Secondary	Level of NETs (Neutrophil Extracellular Traps)	Characterization of the blood coagulation system	Up to 30 days
Secondary	Level of free DNA	Characterization of the blood coagulation system	Up to 30 days
Secondary	Level of Nucleosome	Characterization of the blood coagulation system	Up to 30 days
Secondary	Level of FiO2	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	Up to 29 days
Secondary	VT (Tidal Volume)	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	Up to 29 days
Secondary	Respiratory rate	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	Up to 29 days
Secondary	Level of PaO2	Description of the arterial blood gas parameters under ECCO2R	Up to 29 days
Secondary	Level of PaCO2	Description of the arterial blood gas parameters under ECCO2R	Up to 29 days
Secondary	pH	Description of the arterial blood gas parameters under ECCO2R	Up to 29 days
Secondary	Level of SaO2	Description of the arterial blood gas parameters under ECCO2R	Up to 29 days
Secondary	Heart rate	To describe the patient vital parameters under ECCO2R	Up to 30 days
Secondary	Respiratory rate	To describe the patient vital parameters under ECCO2R	Up to 30 days
Secondary	Blood Pressure	To describe the patient vital parameters under ECCO2R	Up to 30 days
Secondary	Pump speed	Description of the ECCO2R parameters	Up to 29 days
Secondary	Pulsatility setting	Description of the ECCO2R parameters	Up to 29 days
Secondary	Extracorporal blood flow	Description of the ECCO2R parameters	Up to 29 days
Secondary	Extracorporal pressures	Description of the ECCO2R parameters	Up to 29 days