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| ID | Type | Description | Link |
|---|---|---|---|
| DR-2020-302 | Other Identifier | Commission Nationale de l'Informatique et des Libertés | |
| 2020-A00156-33 | Other Identifier | Agence nationale de sécurité du médicament et des produits de santé |
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| Name | Class |
|---|---|
| Xenios AG | INDUSTRY |
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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).
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").
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECCO2R pulsatile configuration | Experimental | Adult patients hospitalized in the medical ICU for whom a treatment by ECCO2R has been indicated. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECCO2R pulsatile configuration | Device | Use of the pulsatile extracorporeal blood flow configuration. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of specific adverse events | To describe the complications under ECCO2R: hemorrhagic, thrombotic and hemolytic adverse events | Up to 30 days |
| Level of von Willebrand factor | To quantify von Willebrand activity/antigenemy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Luc Diehl, PhD | AP-HP, Hôpital Européen Georges Pompidou, Paris | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital européen Georges Pompidou | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28187047 | Background | 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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Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Two years after the last publication
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).
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D008171 | Lung Diseases |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D008173 | Lung Diseases, Obstructive |
| D002908 | Chronic Disease |
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| Up to 30 days |
| Level of P-Selectin | Characterization of the blood coagulation system | Up to 30 days |
| Level of leucoplatelet aggregates | Characterization of the blood coagulation system | Up to 30 days |
| Level of proplatelet aggregates | Characterization of the blood coagulation system | Up to 30 days |
| Level of platelet | Characterization of the blood coagulation system | Up to 30 days |
| Level of microparticles | Characterization of the blood coagulation system | Up to 30 days |
| Level of leucocytes | Characterization of the blood coagulation system | Up to 30 days |
| Level of endothelial cells | Characterization of the blood coagulation system | Up to 30 days |
| Level of NETs (Neutrophil Extracellular Traps) | Characterization of the blood coagulation system | Up to 30 days |
| Level of free DNA | Characterization of the blood coagulation system | Up to 30 days |
| Level of Nucleosome | Characterization of the blood coagulation system | 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 | 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 | 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 | Up to 29 days |
| Level of PaO2 | Description of the arterial blood gas parameters under ECCO2R | Up to 29 days |
| Level of PaCO2 | Description of the arterial blood gas parameters under ECCO2R | Up to 29 days |
| pH | Description of the arterial blood gas parameters under ECCO2R | Up to 29 days |
| Level of SaO2 | Description of the arterial blood gas parameters under ECCO2R | Up to 29 days |
| Heart rate | To describe the patient vital parameters under ECCO2R | Up to 30 days |
| Respiratory rate | To describe the patient vital parameters under ECCO2R | Up to 30 days |
| Blood Pressure | To describe the patient vital parameters under ECCO2R | Up to 30 days |
| Pump speed | Description of the ECCO2R parameters | Up to 29 days |
| Pulsatility setting | Description of the ECCO2R parameters | Up to 29 days |
| Extracorporal blood flow | Description of the ECCO2R parameters | Up to 29 days |
| Extracorporal pressures | Description of the ECCO2R parameters | Up to 29 days |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |