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Effects of Blood Pulsatility on Von Willebrand Factor During ECCO2R (FLOW-ECCO2R)

Primary Purpose

Extracorporeal CO2 Removal, Acute Respiratory Distress Syndrome, Chronic Obstructive Pulmonary Disease Exacerbation

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ECCO2R pulsatile configuration
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extracorporeal CO2 Removal focused on measuring ECCO2R, Willebrand factor, ARDS, COPD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital européen Georges PompidouRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ECCO2R pulsatile configuration

Arm Description

Adult patients hospitalized in the medical ICU for whom a treatment by ECCO2R has been indicated.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rate of specific adverse events
To describe the complications under ECCO2R: hemorrhagic, thrombotic and hemolytic adverse events
Level of von Willebrand factor
To quantify von Willebrand activity/antigenemy
Level of P-Selectin
Characterization of the blood coagulation system
Level of leucoplatelet aggregates
Characterization of the blood coagulation system
Level of proplatelet aggregates
Characterization of the blood coagulation system
Level of platelet
Characterization of the blood coagulation system
Level of microparticles
Characterization of the blood coagulation system
Level of leucocytes
Characterization of the blood coagulation system
Level of endothelial cells
Characterization of the blood coagulation system
Level of NETs (Neutrophil Extracellular Traps)
Characterization of the blood coagulation system
Level of free DNA
Characterization of the blood coagulation system
Level of Nucleosome
Characterization of the blood coagulation system
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
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
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
Level of PaO2
Description of the arterial blood gas parameters under ECCO2R
Level of PaCO2
Description of the arterial blood gas parameters under ECCO2R
pH
Description of the arterial blood gas parameters under ECCO2R
Level of SaO2
Description of the arterial blood gas parameters under ECCO2R
Heart rate
To describe the patient vital parameters under ECCO2R
Respiratory rate
To describe the patient vital parameters under ECCO2R
Blood Pressure
To describe the patient vital parameters under ECCO2R
Pump speed
Description of the ECCO2R parameters
Pulsatility setting
Description of the ECCO2R parameters
Extracorporal blood flow
Description of the ECCO2R parameters
Extracorporal pressures
Description of the ECCO2R parameters

Full Information

First Posted
July 31, 2021
Last Updated
May 12, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Xenios AG
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1. Study Identification

Unique Protocol Identification Number
NCT05079009
Brief Title
Effects of Blood Pulsatility on Von Willebrand Factor During ECCO2R
Acronym
FLOW-ECCO2R
Official Title
Effects of Blood Pulsatility on Von Willebrand Factor During Extracorporeal CO2 Removal (ECCO2R)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 28, 2022 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Xenios AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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").

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extracorporeal CO2 Removal, Acute Respiratory Distress Syndrome, Chronic Obstructive Pulmonary Disease Exacerbation, Pulmonary Disease
Keywords
ECCO2R, Willebrand factor, ARDS, COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ECCO2R pulsatile configuration
Arm Type
Experimental
Arm Description
Adult patients hospitalized in the medical ICU for whom a treatment by ECCO2R has been indicated.
Intervention Type
Device
Intervention Name(s)
ECCO2R pulsatile configuration
Intervention Description
Use of the pulsatile extracorporeal blood flow configuration.
Primary Outcome Measure Information:
Title
Level course of Willebrand Factor high molecular weight multimers in plasma
Description
Quantification of plasma Willebrand Factor high molecular weight multimers by the Hydrasys system
Time Frame
Up to 30 days
Secondary Outcome Measure Information:
Title
Rate of specific adverse events
Description
To describe the complications under ECCO2R: hemorrhagic, thrombotic and hemolytic adverse events
Time Frame
Up to 30 days
Title
Level of von Willebrand factor
Description
To quantify von Willebrand activity/antigenemy
Time Frame
Up to 30 days
Title
Level of P-Selectin
Description
Characterization of the blood coagulation system
Time Frame
Up to 30 days
Title
Level of leucoplatelet aggregates
Description
Characterization of the blood coagulation system
Time Frame
Up to 30 days
Title
Level of proplatelet aggregates
Description
Characterization of the blood coagulation system
Time Frame
Up to 30 days
Title
Level of platelet
Description
Characterization of the blood coagulation system
Time Frame
Up to 30 days
Title
Level of microparticles
Description
Characterization of the blood coagulation system
Time Frame
Up to 30 days
Title
Level of leucocytes
Description
Characterization of the blood coagulation system
Time Frame
Up to 30 days
Title
Level of endothelial cells
Description
Characterization of the blood coagulation system
Time Frame
Up to 30 days
Title
Level of NETs (Neutrophil Extracellular Traps)
Description
Characterization of the blood coagulation system
Time Frame
Up to 30 days
Title
Level of free DNA
Description
Characterization of the blood coagulation system
Time Frame
Up to 30 days
Title
Level of Nucleosome
Description
Characterization of the blood coagulation system
Time Frame
Up to 30 days
Title
Level of FiO2
Description
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
Title
VT (Tidal Volume)
Description
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
Title
Respiratory rate
Description
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
Title
Level of PaO2
Description
Description of the arterial blood gas parameters under ECCO2R
Time Frame
Up to 29 days
Title
Level of PaCO2
Description
Description of the arterial blood gas parameters under ECCO2R
Time Frame
Up to 29 days
Title
pH
Description
Description of the arterial blood gas parameters under ECCO2R
Time Frame
Up to 29 days
Title
Level of SaO2
Description
Description of the arterial blood gas parameters under ECCO2R
Time Frame
Up to 29 days
Title
Heart rate
Description
To describe the patient vital parameters under ECCO2R
Time Frame
Up to 30 days
Title
Respiratory rate
Description
To describe the patient vital parameters under ECCO2R
Time Frame
Up to 30 days
Title
Blood Pressure
Description
To describe the patient vital parameters under ECCO2R
Time Frame
Up to 30 days
Title
Pump speed
Description
Description of the ECCO2R parameters
Time Frame
Up to 29 days
Title
Pulsatility setting
Description
Description of the ECCO2R parameters
Time Frame
Up to 29 days
Title
Extracorporal blood flow
Description
Description of the ECCO2R parameters
Time Frame
Up to 29 days
Title
Extracorporal pressures
Description
Description of the ECCO2R parameters
Time Frame
Up to 29 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cléo Bourgeois
Phone
+331 56 09 56 38
Email
cleo.bourgeois@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Luc Diehl, PhD
Organizational Affiliation
AP-HP, Hôpital Européen Georges Pompidou, Paris
Official's Role
Study Chair
Facility Information:
Facility Name
Hôpital européen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Luc MD Diehl, PhD
Phone
+331 56 09 32 13
Email
jean-luc.diehl@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
IPD Sharing Time Frame
Two years after the last publication
IPD Sharing Access Criteria
Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Data sharing must respect the agreements made with funders. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement. Processing of shared data must comply with European General Data Protection Regulation (GDPR).
Citations:
PubMed Identifier
28187047
Citation
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.
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Effects of Blood Pulsatility on Von Willebrand Factor During ECCO2R

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