Clinical trial NCT04617093: Post-Market Study of Low-flow ECCO2R Using PrismaLung+
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild to Moderate Acute Respiratory Distress Syndrome
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2020-11-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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+.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants achieving ultra-lung protective ventilation (ULPV) 8 and 24 hours following ECCO2R initiation
timeFrame: 8 and 24 hours following ECCO2R initiation
measure: Adverse Events related to study device
timeFrame: Day 1 to Day 28
measure: Adverse Events related to study procedure
timeFrame: Day 1 to Day 28
measure: Adverse Device Effect (ADE)
timeFrame: Day 1 to Day 28
measure: Adverse Events leading to study withdrawal
timeFrame: Day 1 to Day 28
measure: Adverse events of special interest (AESIs)
timeFrame: Day 1 to Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Baxter Investigational Site
city: Colombes
country: France
facility: Baxter Investigational Site
city: Creteil
country: France
facility: Baxter Investigational Site
city: Lille
country: France
facility: Baxter Investigational Site
city: Marseille
country: France
facility: Baxter Investigational Site
city: Montpellier
country: France
facility: Baxter Investigational Site
city: Paris
country: France
facility: Baxter Investigational Site
city: Paris
country: France
facility: Baxter Investigational Site
city: Strasbourg
country: France
facility: Baxter Investigational Site
city: Vandœuvre-lès-Nancy
country: France
facility: Baxter Investigational Site
Study officials:
References: