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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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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+.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total Patient Population | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrismaLung+ | Device | 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. |
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Carbon dioxide clearance after ECCO2R treatment | CO2 clearance (mL/min) will be summarized descriptively by group and in total | 8 hours following ECCO2R initiation |
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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:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Besançon | 25030 | France | |||
| Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41495763 | Derived | Combes A, Levy B, Tapponnier R, Capellier G, Mekontso Dessap A, Duburcq T, Castelain V, Forel JM, Uhel F, Mayaux J, Goldstein J, Kurz J, Harenski K, Montgomery W, Parreno R, Jaber S. A prospective clinical evaluation of new ECCO2R technology in mild to moderate ARDS patients: assessing ultra-lung-protective ventilation with PRISMALUNG. Crit Care. 2026 Jan 6;30(1):15. doi: 10.1186/s13054-025-05827-4. |
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| Day 1 to Day 28 |
| Colombes |
| 92700 |
| France |
| Investigational Site | Créteil | 94010 | France |
| Investigational Site | Lille | 59037 | France |
| Investigational Site | Marseille | 13354 | France |
| Investigational Site | Montpellier | 34295 | France |
| Investigational Site | Paris | 75013 | France |
| Investigational Site | Paris | 75651 | France |
| Investigational Site | Strasbourg | 67098 | France |
| Investigational Site | Vandœuvre-lès-Nancy | 54511 | France |