Effects of Blood Pulsatility on Von Willebrand Factor During ECCO2R

NCT ID: NCT05079009

Last Updated: 2024-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-28
• Study Completion Date: 2023-05-16

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").

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ECCO2R pulsatile configuration

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

Group Type: EXPERIMENTAL

ECCO2R pulsatile configuration

Intervention Type: DEVICE

Use of the pulsatile extracorporeal blood flow configuration.

Interventions

ECCO2R pulsatile configuration

Use of the pulsatile extracorporeal blood flow configuration.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xenios AG

INDUSTRY

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Luc Diehl, PhD

Role: STUDY_CHAIR

AP-HP, Hôpital Européen Georges Pompidou, Paris

Locations

Hôpital européen Georges Pompidou

Paris, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 28187047 (View on PubMed)

Other Identifiers

DR-2020-302

Identifier Type: OTHER

Identifier Source: secondary_id

2020-A00156-33

Identifier Type: OTHER

Identifier Source: secondary_id

APHP180481

Identifier Type: -

Identifier Source: org_study_id