Extracorporeal CO2 RemovalFLOW-ECCO2RNCT05079009
Effects of Blood Pulsatility on Von Willebrand Factor During ECCO2R
A study testing ECCO2R pulsatile configuration in people with Extracorporeal CO2 Removal and Acute Respiratory Distress Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal CO2 Removal, Acute Respiratory Distress Syndrome, Chronic Obstructive Pulmonary Disease Exacerbation
- What is being tested?
- ECCO2R pulsatile configuration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jan 2022to 16 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Blood Pulsatility on Von Willebrand Factor During Extracorporeal CO2 Removal (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).
Read the 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").
- Conditions
- Extracorporeal CO2 Removal, Acute Respiratory Distress Syndrome, Chronic Obstructive Pulmonary Disease Exacerbation, Pulmonary Disease
- Being tested
- ECCO2R pulsatile configuration
- Keywords
- ECCO2R, Willebrand factor, ARDS, COPD
- Medical subject headings
- Respiratory Distress Syndrome, Lung Diseases, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECCO2R pulsatile configurationDevice
Use of the pulsatile extracorporeal blood flow configuration.
| Study group | Role | What they receive |
|---|---|---|
| ECCO2R pulsatile configuration | Experimental | Adult patients hospitalized in the medical ICU for whom a treatment by ECCO2R has been indicated. Receives: Device: ECCO2R pulsatile configuration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level course of Willebrand Factor high molecular weight multimers in plasma
Quantification of plasma Willebrand Factor high molecular weight multimers by the Hydrasys system
Measured: Up to 30 days
Secondary outcomes (26)
Rate of specific adverse events
To describe the complications under ECCO2R: hemorrhagic, thrombotic and hemolytic adverse events
Measured: Up to 30 days
Level of von Willebrand factor
To quantify von Willebrand activity/antigenemy
Measured: Up to 30 days
Level of P-Selectin
Characterization of the blood coagulation system
Measured: Up to 30 days
Level of leucoplatelet aggregates
Characterization of the blood coagulation system
Measured: Up to 30 days
Level of proplatelet aggregates
Characterization of the blood coagulation system
Measured: Up to 30 days
Level of platelet
Characterization of the blood coagulation system
Measured: Up to 30 days
Level of microparticles
Characterization of the blood coagulation system
Measured: Up to 30 days
Level of leucocytes
Characterization of the blood coagulation system
Measured: Up to 30 days
Level of endothelial cells
Characterization of the blood coagulation system
Measured: Up to 30 days
Level of NETs (Neutrophil Extracellular Traps)
Characterization of the blood coagulation system
Measured: Up to 30 days
Level of free DNA
Characterization of the blood coagulation system
Measured: Up to 30 days
Level of Nucleosome
Characterization of the blood coagulation system
Measured: Up to 30 days
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
Measured: Up to 29 days
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
Measured: Up to 29 days
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
Measured: Up to 29 days
Level of PaO2
Description of the arterial blood gas parameters under ECCO2R
Measured: Up to 29 days
Level of PaCO2
Description of the arterial blood gas parameters under ECCO2R
Measured: Up to 29 days
pH
Description of the arterial blood gas parameters under ECCO2R
Measured: Up to 29 days
Level of SaO2
Description of the arterial blood gas parameters under ECCO2R
Measured: Up to 29 days
Heart rate
To describe the patient vital parameters under ECCO2R
Measured: Up to 30 days
Respiratory rate
To describe the patient vital parameters under ECCO2R
Measured: Up to 30 days
Blood Pressure
To describe the patient vital parameters under ECCO2R
Measured: Up to 30 days
Pump speed
Description of the ECCO2R parameters
Measured: Up to 29 days
Pulsatility setting
Description of the ECCO2R parameters
Measured: Up to 29 days
Extracorporal blood flow
Description of the ECCO2R parameters
Measured: Up to 29 days
Extracorporal pressures
Description of the ECCO2R parameters
Measured: Up to 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start28 Jan 2022
- Primary completion16 May 2023
- Study completion16 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extracorporeal CO2 RemovalStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Xenios AG
- Responsible party
- Sponsor
- Investigators
- Jean-Luc Diehl, PhD, Study chair, AP-HP, Hôpital Européen Georges Pompidou, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079009
- Sponsor's protocol ID
- APHP180481
- Other IDs
- DR-2020-302, 2020-A00156-33
- Acronym
- FLOW-ECCO2R
- Status last verified
- May 2024
- First submitted
- 31 Jul 2021
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Publications
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.
PubMed 28187047
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Blood Pulsatility on Von Willebrand Factor During Extracorporeal CO2 Removal (ECCO2R)
- ClinicalTrials.gov ID
- NCT05079009
- Acronym / sponsor ID
- FLOW-ECCO2R / APHP180481
- Conditions
- Extracorporeal CO2 Removal, Acute Respiratory Distress Syndrome, Chronic Obstructive Pulmonary Disease Exacerbation, Pulmonary Disease
- Keywords
- ECCO2R, Willebrand factor, ARDS, COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Xenios AG
- Study start
- 28 Jan 2022 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 16 May 2023 (actual)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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").
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECCO2R pulsatile configuration | Experimental | Device: ECCO2R pulsatile configurationAdult patients hospitalized in the medical ICU for whom a treatment by ECCO2R has been indicated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECCO2R pulsatile configurationUse of the pulsatile extracorporeal blood flow configuration. | Device | ECCO2R pulsatile configuration |
Primary outcome
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
26 secondary outcomes
Rate of specific adverse events
Time frame: Up to 30 days
Level of von Willebrand factor
Time frame: Up to 30 days
Level of P-Selectin
Time frame: Up to 30 days
Level of leucoplatelet aggregates
Time frame: Up to 30 days
Level of proplatelet aggregates
Time frame: Up to 30 days
Level of platelet
Time frame: Up to 30 days
Level of microparticles
Time frame: Up to 30 days
Level of leucocytes
Time frame: Up to 30 days
Level of endothelial cells
Time frame: Up to 30 days
Level of NETs (Neutrophil Extracellular Traps)
Time frame: Up to 30 days
Level of free DNA
Time frame: Up to 30 days
Level of Nucleosome
Time frame: Up to 30 days
Level of FiO2
Time frame: Up to 29 days
VT (Tidal Volume)
Time frame: Up to 29 days
Respiratory rate
Time frame: Up to 29 days
Level of PaO2
Time frame: Up to 29 days
Level of PaCO2
Time frame: Up to 29 days
pH
Time frame: Up to 29 days
Level of SaO2
Time frame: Up to 29 days
Heart rate
Time frame: Up to 30 days
Respiratory rate
Time frame: Up to 30 days
Blood Pressure
Time frame: Up to 30 days
Pump speed
Time frame: Up to 29 days
Pulsatility setting
Time frame: Up to 29 days
Extracorporal blood flow
Time frame: Up to 29 days
Extracorporal pressures
Time frame: Up to 29 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Background: PubMed 28187047Kalbhenn 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.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Luc Diehl, PhD study chair
AP-HP, Hôpital Européen Georges Pompidou, Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECCO2R pulsatile configuration in people with Extracorporeal CO2 Removal and Acute Respiratory Distress Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level course of Willebrand Factor high molecular weight multimers in plasma (time frame: Up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05079009, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.