Effects of Blood Pulsatility on Von Willebrand Factor During ECCO2R

NCT05079009 | Completed

• 3 other identifiers: APHP180481DR-2020-3022020-A00156-33
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

ECCO2R; Willebrand factor; ARDS; COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (26)

• Rate of specific adverse events

  Up to 30 days

• Level of von Willebrand factor

  Up to 30 days

• Level of P-Selectin

  Up to 30 days

• Level of leucoplatelet aggregates

  Up to 30 days

• Level of proplatelet aggregates

  Up to 30 days

Study Arms (1)

ECCO2R pulsatile configuration

EXPERIMENTAL

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

Device: ECCO2R pulsatile configuration

Interventions

ECCO2R pulsatile configuration DEVICE

Use of the pulsatile extracorporeal blood flow configuration.

ECCO2R pulsatile configuration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Negative serum or urinary β-hCG for women of child-bearing potential

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Xenios AG: collaborator

Study Sites (1)

Hôpital européen Georges Pompidou

Paris, 75015, France

Location

Related 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.

  PMID: 28187047 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome; Lung Diseases; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Respiration Disorders; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Luc Diehl, PhD

  AP-HP, Hôpital Européen Georges Pompidou, Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2021
• First Posted: October 15, 2021
• Study Start: January 28, 2022
• Primary Completion: May 16, 2023
• Study Completion: May 16, 2023
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years after the last publication
• 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).

Locations

FR (1)