Post-Market Study of Low-flow ECCO2R Using PrismaLung+

Vantive Health LLC63 enrolled

Overview

PrismaLung+ is intended to provide extracorporeal carbon dioxide removal (ECCO2R) as a standalone therapy or in combination with continuous renal replacement therapy (CRRT). This study is a multi-centre, prospective, open-label, single-arm study. Adult patients with mild or moderate acute respiratory distress syndrome (ARDS) requiring mechanical ventilation were planned to receive ultra-lung protective ventilation (ULPV) associated with ECCO2R using PrismaLung+. The study will assess the capability of PrismaLung+ to allow ULPV, defined as a tidal volume (VT) of 4 mL/kg of predicted body weight, and confirm the safety of PrismaLung+.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mild to Moderate Acute Respiratory Distress Syndrome

Interventions

Overall, up to 60 adult patients will be initiated on ECCO2R using PrismaLung+. A minimum of approximately 15 patients will be treated with ECCO2R using PrismaLung+ as standalone therapy and another minimum of approximately 15 patients will receive ECCO2R using PrismaLung+ in combination with CRRT.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patient age is ≥ 18 years old 2. Patient is expected to receive ECCO2R for a minimum of 24 hours 3. Patient has mild or moderate ARDS according to the Berlin definition: * 100 mm Hg \< PaO2/FiO2 ≤ 300 mm Hg, with PEEP ≥ 5 cm H2O, and * Bilateral lung opacities not fully explained by effusions, lobar/lung collapse, or nodules, and * Respiratory failure not fully explained by cardiac failure or fluid overload 4. Written informed consent to participate in the study from the patient, if possible, or from the identified authorized representative if the patient is unable to provide consent. Exclusion Criteria: 1. Patients body weight \< 30 kg 2. Patients with a contraindication for systemic anticoagulation with heparin 3. Patients with a platelet count \< 50,000/µL 4. Patients on MV \> 7 days 5. Patients with very severe, or stage 4 (as per GOLD staging System) chronic obstructive pulmonary disease (COPD) 6. Current or history of heparin-induced thrombocytopenia 7. Patients who are pregnant and/or breastfeeding 8. Patients not expected to survive the duration of the planned study treatment period (24 hours) 9. Patients currently participating in another interventional clinical study, except if the patient is in an investigational medicinal product study, already in follow-up without further administration of study drug, and has not received any investigational medicinal product within 5 half-lives

Locations (10)

Investigational Site

Besançon, France

Investigational Site

Colombes, France

Investigational Site

Créteil, France

Investigational Site

Lille, France

Investigational Site

Marseille, France

Investigational Site

Montpellier, France

Investigational Site

Paris, France

Investigational Site

Paris, France

Investigational Site

Strasbourg, France

Investigational Site

Vandœuvre-lès-Nancy, France

Outcomes

Primary Outcomes

Number of participants achieving ultra-lung protective ventilation (ULPV) 8 and 24 hours following ECCO2R initiation

Must maintain PaCO2 \< 50 mmHg. ULPV is defined as defined as a tidal volume (VT) of 4 mL/kg of predicted body weight.

Time frame: 8 and 24 hours following ECCO2R initiation

Adverse Events related to study device

Adverse event related to the use of a study device. This definition includes AEs resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the study device. This definition includes any event resulting from use error or from intentional misuse of the study device.

Time frame: Day 1 to Day 28

Adverse Events related to study procedure

Adverse events related to the study procedure (ECCO2R or ECCO2R in combination with CRRT), irrespective of relatedness to the device.

Time frame: Day 1 to Day 28

Adverse Device Effect (ADE)

This includes study device and study procedure related adverse events.

Time frame: Day 1 to Day 28

Adverse Events leading to study withdrawal

Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in patients, users or other persons, in the context of a clinical investigation leading to study withdrawal.

Time frame: Day 1 to Day 28

Adverse events of special interest (AESIs)

The AESI's for this study include significant bleeding events (i.e. require administration of ≥ 1 unit of packed red blood cells (pRBC) or result in a related SAE).

Time frame: Day 1 to Day 28

Secondary Outcomes

Carbon dioxide clearance after ECCO2R treatment

CO2 clearance (mL/min) will be summarized descriptively by group and in total

Time frame: 8 hours following ECCO2R initiation