Mild to Moderate Acute Respiratory Distress Syndrome Clinical Trial
Official title:
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
| Verified date | March 2024 |
| Source | Baxter Healthcare Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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+.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | January 10, 2024 |
| Est. primary completion date | December 5, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Baxter Investigational Site | Besançon | |
| France | Baxter Investigational Site | Colombes | |
| France | Baxter Investigational Site | Creteil | |
| France | Baxter Investigational Site | Lille | |
| France | Baxter Investigational Site | Marseille | |
| France | Baxter Investigational Site | Montpellier | |
| France | Baxter Investigational Site | Paris | |
| France | Baxter Investigational Site | Paris | |
| France | Baxter Investigational Site | Strasbourg | |
| France | Baxter Investigational Site | Vandœuvre-lès-Nancy |
| Lead Sponsor | Collaborator |
|---|---|
| Baxter Healthcare Corporation |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | Adverse Device Effect (ADE) | This includes study device and study procedure related adverse events. | Day 1 to Day 28 | |
| Primary | 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 | |
| Primary | 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 |