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

Launched by BAXTER HEALTHCARE CORPORATION · Oct 30, 2020

Keywords

ClinConnect Summary

No description provided

Gender

ALL

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