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

Study Overview
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Brief Summary
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PrismaLung+ is indicated to provide extracorporeal carbon dioxide removal (ECCO2R) as a stand-alone therapy or in combination with continuous renal replacement therapy (CRRT). This study is intended for patients with increased levels of Carbon Dioxide (CO2) in their blood and ≥ 18 years old, and will treat patients with mild or moderate acute respiratory distress syndrome (ARDS) using PrismaLung+. The study will assess tidal volume reduction and confirm the safety of PrismaLung+.

Official Title
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A Post-Market Study of Performance and Safety of Low-flow Extracorporeal Carbon Dioxide Removal Using PrismaLung+ in Patients With Mild to Moderate Acute Respiratory Distress Syndrome

Conditions
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Mild to Moderate Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Device: PrismaLung+


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient age is ≥ 18 years old Patient is expected to receive ECCO2R for a minimum of 24 hours 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 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: Patients body weight < 30 kg Patients with a contraindication for systemic anticoagulation with heparin Patients with a platelet count < 50,000/µL Patients on MV > 7 days Patients with very severe, or stage 4 (as per GOLD staging System) chronic obstructive pulmonary disease (COPD) Current or history of heparin-induced thrombocytopenia Patients who are pregnant and/or breastfeeding Patients not expected to survive the duration of the planned study treatment period (24 hours) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Total Patient Population<br>The planned PrismaLung+ treatment period for this study is 24 hours. Neuromuscular blockade and sedation will be required for the first 24 hours of ECCO2R treatment and thereafter, will be used at the discretion of the attending physician. Patients will require systemic anticoagulation with heparin during ECCO2R treatment. Blood warming during ECCO2R treatment will occur using the TherMax blood warmer. | Device: PrismaLung+<br>* Overall, 50 adult patients will be initiated on ECCO2R using PrismaLung+. A minimum of approximately 15 patients will be treated with ECCO2R using PrismaLung+ as stand-alone therapy and another minimum of approximately 15 patients (maximum of 20) will receive ECCO2R using PrismaLung+ in combination with CRRT.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Day 1 to Day 28 | 
| Adverse Device Effect (ADE) | This includes study device and study procedure related adverse events. | 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. | 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). | Day 1 to Day 28 |